acuTENSNCT05410288
Acu-TENS and Acupressure on the Sleep Quality
A study testing Acu-TENS, acupressure+SHP and sleep hygiene program(SHP) in people with acuTENS and Sleep Quality, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The study aims to investigate the effects of two non-invasive acupuncture methodologies applied to three selected acupoints on the sleep quality of older adults with insomnia. The investigators invite participants to participate in the study (12 treatments [3 times/week, 4 weeks in total], 3 tests), which will take… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- acuTENS, Sleep Quality, Insomnia
- What is being tested?
- Acu-TENS, acupressure+SHP and sleep hygiene program(SHP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 55 years or older; and
- self-reported poor sleep quality (PSQI, scores ≥ 6) in the past 4 weeks
Who cannot join
- an amputation or recent fracture of upper or lower limbs;
- a severe disease that precludes the receipt of Acu-TENS or acupressure (e.g., renal impairment; epilepsy; cardiac pace-mark or another electrical or metal implant in participants' body);
- taking medication that may affect sleep;
- skin lesions, infection, or inflammation near selected acupoints; or
- a psychiatrically diagnosed mental disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation of the Effects of Acu-TENS and Acupressure on the Sleep Quality of Older Adults With Insomnia: A Pilot Randomized, Placebo-controlled Clinical Trial
The study aims to investigate the effects of two non-invasive acupuncture methodologies applied to three selected acupoints on the sleep quality of older adults with insomnia.
The investigators invite participants to participate in the study (12 treatments [3 times/week, 4 weeks in total], 3 tests), which will take about 2 months in total. Participants will be randomly allocated to three independent groups, i.e., a placebo group or one of two treatment groups, viz., a transcutaneous electrical nerve-stimulation group (Acu-TENS) or an acupressure group. The Acu-TENS group will receive Acu-TENS + a sleep hygiene program (SHP). The acupressure group will receive acupressure + SHP. The placebo group will receive a placebo stimulation+ SHP. Each group will have a 4-week treatment comprising thrice-weekly 30-min sessions of treatment.
For Acu-TENS, electrodes will be attached to participants' sleep-related acupoints for 30 minutes. For acupressure, the investigators will guide participants to apply pressure to each sleep-related acupoint for 5 minutes, for a total of 30 minutes. The process of Sham Acu-TENS stimulation will be the same as Acu-TENS, but the instrument model is different. SHP is a training course in which the investigators will guide participants on how to improve participants' sleep quality by adjusting participants' lifestyle. The sleep quality (survey and actigraphy), insomnia index, heart rate variability, level of fatigue (survey), mood (survey) and quality of life (survey) will be measured at the baseline assessment (before the treatment), post-treatment assessment (after the four weeks treatment) and follow-up assessment (two weeks after the treatment ended). The investigators will give participants a watch to wear for one week during sleep measurement and then please return it. The watch will record participants' sleep data. For the heart rate variability measurement, participants will need to wear a heart rate monitor in the lab for a short period. After the trials, Participants will have the opportunity to know participants' level of sleep quality and some mental conditions (i.e., mood, fatigue, quality of life). Participants may experience mild skin irritation during treatment. If participants feel uncomfortable, please inform the researcher to reduce the irritation to a relatively comfortable level.
Read the detailed description
Insomnia is the most common sleep disorder that affects older adults. This proposed study aims to investigate the effects of two acupuncture methodology applied to three selected acupoints on the sleep quality of older adults with insomnia. The study will be a single-blind randomized controlled trial with a pre-post design and involve three parallel groups of older adult participants (aged > 55 years) diagnosed with insomnia. The participants will be randomly allocated to three independent groups, i.e., a placebo group or one of two treatment groups, viz., a transcutaneous electrical nerve-stimulation group (Acu-TENS) or an acupressure group. The Acu-TENS group will receive a 4-week treatment comprising thrice-weekly 30-min sessions of Acu-TENS + a sleep hygiene program (SHP). The acupressure group will receive acupressure + SHP. The selected acupoints will be bilateral Sanyinjiao (SP6) on the legs and Shenmen (HT7) and Neiguan (PC6) on the wrists. The placebo group will receive a placebo stimulation+ SHP. The primary outcomes of the study will be sleep quality, insomnia index as well as actigraphy. The secondary outcomes will be heart rate variability, level of fatigue, mood, and quality of life. All the outcomes will be measured at the baseline assessment (before the treatment), post-treatment assessment (after the four weeks treatment) and follow-up assessment (two weeks after the treatment ended). It is hypothesized that the Acu-TENS + SHP treatment will better alleviate insomnia in participants than acupressure + SHP or placebo stimulation + SHP.
- Conditions
- acuTENS, Sleep Quality, Insomnia, Acupressure
- Being tested
- Acu-TENS, acupressure+SHP, placebo stimulation+SHP, sleep hygiene program(SHP)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acu-TENSDevice
A TENS stimulator will be used (NeuroTrac TENS; Verity Medical Ltd., Wexford, Ireland). Electrodes will be placed over selected acupoints (i.e., bilateral SP6, PC6 and HT7) and connected to the TENS stimulator. These acupoints are selected according to the traditional Chinese medicine and results of previous studies. The stimulation will be lasted 30-min for each session. The frequency of the stimulation parameter's waveform will be set to 100 Hz and the square pulses will be set to 0.2-ms. The intensity of the stimulation will be below motor threshold and lower than the intolerable level, and hence, participants will feel a pleasant and mild aching sensation.
acupressure+SHPOther
Participants in the acupressure group will receive acupressure coupled with SHP. The acupressure protocol was developed based on a protocol recommended by a review and will comprise the following: (1) applying consistent finger-tip pressure of 3-5 kg, with rotational movements; (2) counterclockwise and then clockwise circular motions for 2.5-min each; (3) confirming the precision of the acupressure based on participants feeling pain, numbness, distension, or warmth at the point of application; and (4) an acupoint sequence from the leg to the head, first on the left side of the body and then on the right side of the body; and (5) a 5-min treatment on each acupoint (i.e., bilateral SP6, PC6, and HT7) in each 30-min session. The SHP is the same with Acu-TENS+SHP group.
placebo stimulation+SHPOther
Participants in the placebo stimulation + SHP group will receive 30-minute placebo stimulation from identical-looking TENS devices with the electrical circuit disconnected inside.
sleep hygiene program(SHP)Other
SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits.
| Study group | Role | What they receive |
|---|---|---|
| Acu-TENS+SHP | Experimental | Participants in the Acu-TENS group will receive Acu-TENS coupled with a sleep hygiene program (SHP). 4 weeks and comprise thrice-weekly 30-min sessions. Receives: Device: Acu-TENS; Other: sleep hygiene program(SHP) |
| acupressure+SHP | Experimental | The acupressure group will receive acupressure and SHP. 4 weeks and comprise thrice-weekly 30-min sessions. Receives: Other: acupressure+SHP; Other: sleep hygiene program(SHP) |
| placebo stimulation+SHP | Placebo comparator | The placebo group will receive a placebo stimulation and SHP. 4 weeks and comprise thrice-weekly 30-min sessions. Receives: Other: placebo stimulation+SHP; Other: sleep hygiene program(SHP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index (PSQI)
The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.
Measured: T0, baseline
Pittsburgh sleep quality index (PSQI)
The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.
Measured: T1, post (4th week)
Pittsburgh sleep quality index (PSQI)
The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.
Measured: T2, follow-up(6th week)
Insomnia severity index (ISI)
The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.
Measured: T0, baseline
Insomnia severity index (ISI)
The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.
Measured: T1, post (4th week)
Insomnia severity index (ISI)
The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.
Measured: T2, follow-up(6th week)
Total sleep time
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T0, baseline
Total sleep time
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T1, post (4th week)
Total sleep time
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T2, follow-up(6th week)
Sleep efficiency
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T0, baseline
Sleep efficiency
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T1, post (4th week)
Sleep efficiency
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T2, follow-up(6th week)
Sleep onset latency
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T1, post (4th week)
Sleep onset latency
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T0, baseline
Sleep onset latency
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T2, follow-up(6th week)
Time awake after sleep onset
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T1, post (4th week)
Time awake after sleep onset
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T0, baseline
Time awake after sleep onset
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Measured: T2, follow-up(6th week)
Secondary outcomes (12)
Heart Rate Variability (HRV)
Heart rate and heart rate variability will be measured by electrocardiography (ECG; SphygmoCor, AtCor Medical, Sydney, Australia, or equivalent device), using a device that acquires, stores, and processes electrocardiogram signals. Participants will be measured in the morning between 8:00 to 11:00 am. The sympathetic nervous activity, and the high frequency will be used to indicate parasympathetic nervous activity.
Measured: T0, baseline
Heart Rate Variability (HRV)
Heart rate and heart rate variability will be measured by electrocardiography (ECG; SphygmoCor, AtCor Medical, Sydney, Australia, or equivalent device), using a device that acquires, stores, and processes electrocardiogram signals. Participants will be measured in the morning between 8:00 to 11:00 am. The sympathetic nervous activity, and the high frequency will be used to indicate parasympathetic nervous activity.
Measured: T1, post (4th week)
Heart Rate Variability (HRV)
Heart rate and heart rate variability will be measured by electrocardiography (ECG; SphygmoCor, AtCor Medical, Sydney, Australia, or equivalent device), using a device that acquires, stores, and processes electrocardiogram signals. Participants will be measured in the morning between 8:00 to 11:00 am. The sympathetic nervous activity, and the high frequency will be used to indicate parasympathetic nervous activity.
Measured: T2, follow-up(6th week)
Depression Anxiety Stress Scale
Participants' mood will be measured using the Depression Anxiety Stress Scale, a 21-item survey that assesses depression, anxiety, and stress. Each index (i.e., depression, anxiety, and stress) comprises seven items. The scores ranges from 0 to 42. Higher score indicates more sever symptom. The reliability of this scale was confirmed in previous research.
Measured: T0, baseline
Depression Anxiety Stress Scale
Participants' mood will be measured using the Depression Anxiety Stress Scale, a 21-item survey that assesses depression, anxiety, and stress. Each index (i.e., depression, anxiety, and stress) comprises seven items. The scores ranges from 0 to 42. Higher score indicates more sever symptom. The reliability of this scale was confirmed in previous research.
Measured: T1, post (4th week)
Depression Anxiety Stress Scale
Participants' mood will be measured using the Depression Anxiety Stress Scale, a 21-item survey that assesses depression, anxiety, and stress. Each index (i.e., depression, anxiety, and stress) comprises seven items. The scores ranges from 0 to 42. Higher score indicates more sever symptom. The reliability of this scale was confirmed in previous research.
Measured: T2, follow-up(6th week)
The Fatigue Assessment Scale
The Fatigue Assessment Scale will be used to measure participants' general fatigue. It is a 10-item survey, of which 5 items assess physical fatigue and the remaining 5 items assess mental fatigue. The total score ranges from 10 to 50, and a total score ≥ 22 indicates fatigue. The translated Chinese version will be used in the proposed study.
Measured: T0, baseline
The Fatigue Assessment Scale
The Fatigue Assessment Scale will be used to measure participants' general fatigue. It is a 10-item survey, of which 5 items assess physical fatigue and the remaining 5 items assess mental fatigue. The total score ranges from 10 to 50, and a total score ≥ 22 indicates fatigue. The translated Chinese version will be used in the proposed study.
Measured: T1, post (4th week)
The Fatigue Assessment Scale
The Fatigue Assessment Scale will be used to measure participants' general fatigue. It is a 10-item survey, of which 5 items assess physical fatigue and the remaining 5 items assess mental fatigue. The total score ranges from 10 to 50, and a total score ≥ 22 indicates fatigue. The translated Chinese version will be used in the proposed study.
Measured: T2, follow-up(6th week)
Health-related Quality of Life (QoL)
The 12-item Short-Form Survey will be used to measure participants' QoL. This instrument contains eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The total score ranges from 0 to 100, with a higher score indicating better QoL. The translated Cantonese version will be used in this proposed study .
Measured: T0, baseline
Health-related Quality of Life (QoL)
The 12-item Short-Form Survey will be used to measure participants' QoL. This instrument contains eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The total score ranges from 0 to 100, with a higher score indicating better QoL. The translated Cantonese version will be used in this proposed study .
Measured: T1, post (4th week)
Health-related Quality of Life (QoL)
The 12-item Short-Form Survey will be used to measure participants' QoL. This instrument contains eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The total score ranges from 0 to 100, with a higher score indicating better QoL. The translated Cantonese version will be used in this proposed study .
Measured: T2, follow-up(6th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jun 2022
- Primary completion1 Jan 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for acuTENSStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamay Ng, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410288
- Sponsor's protocol ID
- 2022ShamayAcu-tens
- Status last verified
- Sep 2023
- First submitted
- 31 May 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao H, Pan X, Li H, Liu J. Acupuncture for treatment of insomnia: a systematic review of randomized controlled trials. J Altern Complement Med. 2009 Nov;15(11):1171-86. doi: 10.1089/acm.2009.0041.
PubMed 19922248Chiou YF, Yeh ML, Wang YJ. Transcutaneous Electrical Nerve Stimulation on Acupuncture Points Improves Myofascial Pain, Moods, and Sleep Quality. Rehabil Nurs. 2020 Jul/Aug;45(4):225-233. doi: 10.1097/RNJ.0000000000000198.
PubMed 30694996Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011 Mar;21(1):41-53. doi: 10.1007/s11065-010-9154-6. Epub 2011 Jan 12.
PubMed 21225347Flachskampf FA, Gallasch J, Gefeller O, Gan J, Mao J, Pfahlberg AB, Wortmann A, Klinghammer L, Pflederer W, Daniel WG. Randomized trial of acupuncture to lower blood pressure. Circulation. 2007 Jun 19;115(24):3121-9. doi: 10.1161/CIRCULATIONAHA.106.661140. Epub 2007 Jun 4.
PubMed 17548730Fu CW, Shu Q, Jiao Y, Wu T, Song AQ, Zhu QC, Zhang WP. A comparison of noninvasive and invasive acupuncture in preventing postoperative nausea and vomiting: A protocol for systematic review and Bayesian network meta-analysis. Medicine (Baltimore). 2020 Jul 31;99(31):e21544. doi: 10.1097/MD.0000000000021544.
PubMed 32756210Gibson W, Wand BM, Meads C, Catley MJ, O'Connell NE. Transcutaneous electrical nerve stimulation (TENS) for chronic pain - an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD011890. doi: 10.1002/14651858.CD011890.pub2.
PubMed 30776855He W, Li M, Zuo L, Wang M, Jiang L, Shan H, Han X, Yang K, Han X. Acupuncture for treatment of insomnia: An overview of systematic reviews. Complement Ther Med. 2019 Feb;42:407-416. doi: 10.1016/j.ctim.2018.12.020. Epub 2018 Dec 28.
PubMed 30670275He Y, Guo X, May BH, Zhang AL, Liu Y, Lu C, Mao JJ, Xue CC, Zhang H. Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis. JAMA Oncol. 2020 Feb 1;6(2):271-278. doi: 10.1001/jamaoncol.2019.5233.
PubMed 31855257Johnson MI, Bjordal JM. Transcutaneous electrical nerve stimulation for the management of painful conditions: focus on neuropathic pain. Expert Rev Neurother. 2011 May;11(5):735-53. doi: 10.1586/ern.11.48.
PubMed 21539490Kathol RG, Arnedt JT. Cognitive Behavioral Therapy for Chronic Insomnia: Confronting the Challenges to Implementation. Ann Intern Med. 2016 Jul 19;165(2):149-50. doi: 10.7326/M16-0359. Epub 2016 May 3. No abstract available.
PubMed 27136604Khan MS, Aouad R. The Effects of Insomnia and Sleep Loss on Cardiovascular Disease. Sleep Med Clin. 2017 Jun;12(2):167-177. doi: 10.1016/j.jsmc.2017.01.005. Epub 2017 Mar 25.
PubMed 28477772Kuppermann M, Lubeck DP, Mazonson PD, Patrick DL, Stewart AL, Buesching DP, Fifer SK. Sleep problems and their correlates in a working population. J Gen Intern Med. 1995 Jan;10(1):25-32. doi: 10.1007/BF02599573.
PubMed 7699483Liu Y, Zhang J, Lam SP, Yu MW, Li SX, Zhou J, Chan JW, Chan NY, Li AM, Wing YK. Help-seeking behaviors for insomnia in Hong Kong Chinese: a community-based study. Sleep Med. 2016 May;21:106-13. doi: 10.1016/j.sleep.2016.01.006. Epub 2016 Feb 12.
PubMed 27448480Lu MJ, Lin ST, Chen KM, Tsang HY, Su SF. Acupressure improves sleep quality of psychogeriatric inpatients. Nurs Res. 2013 Mar-Apr;62(2):130-7. doi: 10.1097/NNR.0b013e3182781524.
PubMed 23302821Matthews EE, Arnedt JT, McCarthy MS, Cuddihy LJ, Aloia MS. Adherence to cognitive behavioral therapy for insomnia: a systematic review. Sleep Med Rev. 2013 Dec;17(6):453-64. doi: 10.1016/j.smrv.2013.01.001. Epub 2013 Apr 17.
PubMed 23602124
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation of the Effects of Acu-TENS and Acupressure on the Sleep Quality of Older Adults With Insomnia: A Pilot Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05410288
- Acronym / sponsor ID
- 2022ShamayAcu-tens
- Conditions
- acuTENS, Sleep Quality, Insomnia, Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the effects of two non-invasive acupuncture methodologies applied to three selected acupoints on the sleep quality of older adults with insomnia.
The investigators invite participants to participate in the study (12 treatments [3 times/week, 4 weeks in total], 3 tests), which will take about 2 months in total. Participants will be randomly allocated to three independent groups, i.e., a placebo group or one of two treatment groups, viz., a transcutaneous electrical nerve-stimulation group (Acu-TENS) or an acupressure group. The Acu-TENS group will receive Acu-TENS + a sleep hygiene program (SHP). The acupressure group will receive acupressure + SHP. The placebo group will receive a placebo stimulation+ SHP. Each group will have a 4-week treatment comprising thrice-weekly 30-min sessions of treatment.
For Acu-TENS, electrodes will be attached to participants' sleep-related acupoints for 30 minutes. For acupressure, the investigators will guide participants to apply pressure to each sleep-related acupoint for 5 minutes, for a total of 30 minutes. The process of Sham Acu-TENS stimulation will be the same as Acu-TENS, but the instrument model is different. SHP is a training course in which the investigators will guide participants on how to improve participants' sleep quality by adjusting participants' lifestyle. The sleep quality (survey and actigraphy), insomnia index, heart rate variability, level of fatigue (survey), mood (survey) and quality of life (survey) will be measured at the baseline assessment (before the treatment), post-treatment assessment (after the four weeks treatment) and follow-up assessment (two weeks after the treatment ended). The investigators will give participants a watch to wear for one week during sleep measurement and then please return it. The watch will record participants' sleep data. For the heart rate variability measurement, participants will need to wear a heart rate monitor in the lab for a short period. After the trials, Participants will have the opportunity to know participants' level of sleep quality and some mental conditions (i.e., mood, fatigue, quality of life). Participants may experience mild skin irritation during treatment. If participants feel uncomfortable, please inform the researcher to reduce the irritation to a relatively comfortable level.
Detailed description
Insomnia is the most common sleep disorder that affects older adults. This proposed study aims to investigate the effects of two acupuncture methodology applied to three selected acupoints on the sleep quality of older adults with insomnia. The study will be a single-blind randomized controlled trial with a pre-post design and involve three parallel groups of older adult participants (aged > 55 years) diagnosed with insomnia. The participants will be randomly allocated to three independent groups, i.e., a placebo group or one of two treatment groups, viz., a transcutaneous electrical nerve-stimulation group (Acu-TENS) or an acupressure group. The Acu-TENS group will receive a 4-week treatment comprising thrice-weekly 30-min sessions of Acu-TENS + a sleep hygiene program (SHP). The acupressure group will receive acupressure + SHP. The selected acupoints will be bilateral Sanyinjiao (SP6) on the legs and Shenmen (HT7) and Neiguan (PC6) on the wrists. The placebo group will receive a placebo stimulation+ SHP. The primary outcomes of the study will be sleep quality, insomnia index as well as actigraphy. The secondary outcomes will be heart rate variability, level of fatigue, mood, and quality of life. All the outcomes will be measured at the baseline assessment (before the treatment), post-treatment assessment (after the four weeks treatment) and follow-up assessment (two weeks after the treatment ended). It is hypothesized that the Acu-TENS + SHP treatment will better alleviate insomnia in participants than acupressure + SHP or placebo stimulation + SHP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acu-TENS+SHP | Experimental | Device: Acu-TENS, Other: sleep hygiene program(SHP)Participants in the Acu-TENS group will receive Acu-TENS coupled with a sleep hygiene program (SHP). 4 weeks and comprise thrice-weekly 30-min sessions. |
| acupressure+SHP | Experimental | Other: acupressure+SHP, Other: sleep hygiene program(SHP)The acupressure group will receive acupressure and SHP. 4 weeks and comprise thrice-weekly 30-min sessions. |
| placebo stimulation+SHP | Placebo comparator | Other: placebo stimulation+SHP, Other: sleep hygiene program(SHP)The placebo group will receive a placebo stimulation and SHP. 4 weeks and comprise thrice-weekly 30-min sessions. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 55 years or older; and
- self-reported poor sleep quality (PSQI, scores ≥ 6) in the past 4 weeks
Key exclusion criteria (5 listed)
- an amputation or recent fracture of upper or lower limbs;
- a severe disease that precludes the receipt of Acu-TENS or acupressure (e.g., renal impairment; epilepsy; cardiac pace-mark or another electrical or metal implant in participants' body);
- taking medication that may affect sleep;
- skin lesions, infection, or inflammation near selected acupoints; or
- a psychiatrically diagnosed mental disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acu-TENSA TENS stimulator will be used (NeuroTrac TENS; Verity Medical Ltd., Wexford, Ireland). Electrodes will be placed over selected acupoints (i.e., bilateral SP6, PC6 and HT7) and connected to the TENS stimulator. These acupoints are selected according to the traditional Chinese medicine and results of previous studies. The stimulation will be lasted 30-min for each session. The frequency of the stimulation parameter's waveform will be set to 100 Hz and the square pulses will be set to 0.2-ms. The intensity of the stimulation will be below motor threshold and lower than the intolerable level, and hence, participants will feel a pleasant and mild aching sensation. | Device | Acu-TENS+SHP |
| acupressure+SHPParticipants in the acupressure group will receive acupressure coupled with SHP. The acupressure protocol was developed based on a protocol recommended by a review and will comprise the following: (1) applying consistent finger-tip pressure of 3-5 kg, with rotational movements; (2) counterclockwise and then clockwise circular motions for 2.5-min each; (3) confirming the precision of the acupressure based on participants feeling pain, numbness, distension, or warmth at the point of application; and (4) an acupoint sequence from the leg to the head, first on the left side of the body and then on the right side of the body; and (5) a 5-min treatment on each acupoint (i.e., bilateral SP6, PC6, and HT7) in each 30-min session. The SHP is the same with Acu-TENS+SHP group. | Other | acupressure+SHP |
| placebo stimulation+SHPParticipants in the placebo stimulation + SHP group will receive 30-minute placebo stimulation from identical-looking TENS devices with the electrical circuit disconnected inside. | Other | placebo stimulation+SHP |
| sleep hygiene program(SHP)SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits. | Other | Acu-TENS+SHP, acupressure+SHP, placebo stimulation+SHP |
Primary outcome
Pittsburgh sleep quality index (PSQI)
Time frame: T0, baseline
The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.
Pittsburgh sleep quality index (PSQI)
Time frame: T1, post (4th week)
The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.
Pittsburgh sleep quality index (PSQI)
Time frame: T2, follow-up(6th week)
The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.
Insomnia severity index (ISI)
Time frame: T0, baseline
The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.
Insomnia severity index (ISI)
Time frame: T1, post (4th week)
The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.
Insomnia severity index (ISI)
Time frame: T2, follow-up(6th week)
The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.
Total sleep time
Time frame: T0, baseline
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Total sleep time
Time frame: T1, post (4th week)
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Total sleep time
Time frame: T2, follow-up(6th week)
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Sleep efficiency
Time frame: T0, baseline
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Sleep efficiency
Time frame: T1, post (4th week)
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Sleep efficiency
Time frame: T2, follow-up(6th week)
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Sleep onset latency
Time frame: T1, post (4th week)
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Sleep onset latency
Time frame: T0, baseline
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Sleep onset latency
Time frame: T2, follow-up(6th week)
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Time awake after sleep onset
Time frame: T1, post (4th week)
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Time awake after sleep onset
Time frame: T0, baseline
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
Time awake after sleep onset
Time frame: T2, follow-up(6th week)
Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.
12 secondary outcomes
Heart Rate Variability (HRV)
Time frame: T0, baseline
Heart Rate Variability (HRV)
Time frame: T1, post (4th week)
Heart Rate Variability (HRV)
Time frame: T2, follow-up(6th week)
Depression Anxiety Stress Scale
Time frame: T0, baseline
Depression Anxiety Stress Scale
Time frame: T1, post (4th week)
Depression Anxiety Stress Scale
Time frame: T2, follow-up(6th week)
The Fatigue Assessment Scale
Time frame: T0, baseline
The Fatigue Assessment Scale
Time frame: T1, post (4th week)
The Fatigue Assessment Scale
Time frame: T2, follow-up(6th week)
Health-related Quality of Life (QoL)
Time frame: T0, baseline
Health-related Quality of Life (QoL)
Time frame: T1, post (4th week)
Health-related Quality of Life (QoL)
Time frame: T2, follow-up(6th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 19922248Cao H, Pan X, Li H, Liu J. Acupuncture for treatment of insomnia: a systematic review of randomized controlled trials. J Altern Complement Med. 2009 Nov;15(11):1171-86. doi: 10.1089/acm.2009.0041.
- Background: PubMed 30694996Chiou YF, Yeh ML, Wang YJ. Transcutaneous Electrical Nerve Stimulation on Acupuncture Points Improves Myofascial Pain, Moods, and Sleep Quality. Rehabil Nurs. 2020 Jul/Aug;45(4):225-233. doi: 10.1097/RNJ.0000000000000198.
- Background: PubMed 21225347Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011 Mar;21(1):41-53. doi: 10.1007/s11065-010-9154-6. Epub 2011 Jan 12.
- Background: PubMed 17548730Flachskampf FA, Gallasch J, Gefeller O, Gan J, Mao J, Pfahlberg AB, Wortmann A, Klinghammer L, Pflederer W, Daniel WG. Randomized trial of acupuncture to lower blood pressure. Circulation. 2007 Jun 19;115(24):3121-9. doi: 10.1161/CIRCULATIONAHA.106.661140. Epub 2007 Jun 4.
- Background: PubMed 32756210Fu CW, Shu Q, Jiao Y, Wu T, Song AQ, Zhu QC, Zhang WP. A comparison of noninvasive and invasive acupuncture in preventing postoperative nausea and vomiting: A protocol for systematic review and Bayesian network meta-analysis. Medicine (Baltimore). 2020 Jul 31;99(31):e21544. doi: 10.1097/MD.0000000000021544.
- Background: PubMed 30776855Gibson W, Wand BM, Meads C, Catley MJ, O'Connell NE. Transcutaneous electrical nerve stimulation (TENS) for chronic pain - an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2019 Feb 19;2(2):CD011890. doi: 10.1002/14651858.CD011890.pub2.
- Background: PubMed 30670275He W, Li M, Zuo L, Wang M, Jiang L, Shan H, Han X, Yang K, Han X. Acupuncture for treatment of insomnia: An overview of systematic reviews. Complement Ther Med. 2019 Feb;42:407-416. doi: 10.1016/j.ctim.2018.12.020. Epub 2018 Dec 28.
- Background: PubMed 31855257He Y, Guo X, May BH, Zhang AL, Liu Y, Lu C, Mao JJ, Xue CC, Zhang H. Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis. JAMA Oncol. 2020 Feb 1;6(2):271-278. doi: 10.1001/jamaoncol.2019.5233.
- Background: PubMed 21539490Johnson MI, Bjordal JM. Transcutaneous electrical nerve stimulation for the management of painful conditions: focus on neuropathic pain. Expert Rev Neurother. 2011 May;11(5):735-53. doi: 10.1586/ern.11.48.
- Background: PubMed 27136604Kathol RG, Arnedt JT. Cognitive Behavioral Therapy for Chronic Insomnia: Confronting the Challenges to Implementation. Ann Intern Med. 2016 Jul 19;165(2):149-50. doi: 10.7326/M16-0359. Epub 2016 May 3. No abstract available.
- Background: PubMed 28477772Khan MS, Aouad R. The Effects of Insomnia and Sleep Loss on Cardiovascular Disease. Sleep Med Clin. 2017 Jun;12(2):167-177. doi: 10.1016/j.jsmc.2017.01.005. Epub 2017 Mar 25.
- Background: PubMed 7699483Kuppermann M, Lubeck DP, Mazonson PD, Patrick DL, Stewart AL, Buesching DP, Fifer SK. Sleep problems and their correlates in a working population. J Gen Intern Med. 1995 Jan;10(1):25-32. doi: 10.1007/BF02599573.
- Individual participant dataSharing planned: No
Related trials for acuTENS
Active, not recruiting
AcuTENS for Pain Relief During TRUS-Guided Prostate Biopsy
Prostate Cancer, Procedural Pain Relief
Recruiting
Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck
Head and Neck Cancer
Recruiting
Effect of Transcutaneous Acupoint Electrical Stimulation (TAES) on Postoperative Cough in Lung Cancer
Postoperative Cough, Lung Cancer
Not yet recruiting
The Effect of Patient-Controlled TEAS vs Sham TEAS for Improve Quality of Life in Patients With Cancer Pain
Cancer Pain
Not yet recruiting
Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor
Postoperative Cognitive Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acu-TENS, acupressure+SHP and sleep hygiene program(SHP) in people with acuTENS and Sleep Quality, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index (PSQI) (time frame: T0, baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410288, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.