InsomniaNCT02970695
Auriculotherapy on Older People With Insomnia
A study testing magneto-auriculotherapy (MAT) and Laser auriculotherapy (LAT) in people with Insomnia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the improvement of sleep conditions and quality of life on the elders with insomnia. Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on the improvement of sleep conditions and quality of life in… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- magneto-auriculotherapy (MAT) and Laser auriculotherapy (LAT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2016to 2 May 2018
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Volunteers who are aged 65 or above
- Report having difficulty falling or staying asleep, and/or frequent nocturnal awakenings
- At least three nights per week, sleep disturbance has lasted for a minimum of six months
- Their sleep is of poor quality as indicated by a PSQI score greater than five.
Who cannot join
- profound physical illness, such as stroke
- diagnosed with obstructive sleep apnoea
- having a hearing aid or pacemaker in situ (to prevent the magnetic pellets from interfering with the devices)
- receiving AT within the preceding 6 months,
- suffering from aural injuries or infections, and
- inability to understand instructions or give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Auriculotherapy on Older People With Insomnia
Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the improvement of sleep conditions and quality of life on the elders with insomnia.
Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on the improvement of sleep conditions and quality of life in the elderly with insomnia.
Read more
Design and subjects This is a 3-arm double-blinded randomised trial. Subjects aged ≥65 and exhibit poor sleep conditions are recruited.
Interventions Group 1: Subjects will receive a deactivated laser treatment followed by MAT. Group 2: Subjects will receive LAT and placebo MAT. Group 3: Subjects will receive a combined approach (LAT plus MAT).
The treatment will be delivered 3 times/week, with a 6-week treatment period, on seven specific auricular points.
Main outcome measures Sleep conditions and quality of life will be evaluated at baseline; end of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods.
Data analysis Descriptive statistics, chi-square analysis, ANOVA, paired t-test, and mixed effect modeling will be conducted as appropriate.
Expected results This study would advance our knowledge the optimum treatment protocol of AT in the improvement of the sleep conditions of the elderly population.
- Conditions
- Insomnia
- Being tested
- magneto-auriculotherapy (MAT), Laser auriculotherapy (LAT)
- Keywords
- insomnia, older people, auriculotherapy
- 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.
magneto-auriculotherapy (MAT)Device
Subjects will then receive MAT. The magnetic pellets will have ~200 gauss/pellet magnetic flux densities on average, with a diameter of 1.76 mm.The experimental object will be applied to the seven selected acupoints as detected by an acupoint detector. Only one ear will receive treatment at a time, and the pellets will remain in situ for two days before the next change.
Laser auriculotherapy (LAT)Device
A laser device (Pointer Pulse™)15 will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm,2 and a pulse of 10 Hz, which is a common acceptable dosage for clinical use. 16, 17 This application is a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer. A 1-minute treatment using the continuous mode of the device will be directly applied to the selected acupoints. Laser protective goggles will be provided to the subjects and the researcher for eyes protection
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm 1 | Active comparator | To achieve a blinding and placebo effect of the subject, the laser device will be switched to "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of MAT. The subjects will be asked to wear a pair of laser protective goggles so as to "blind" them during treatment. Receives: Device: magneto-auriculotherapy (MAT) |
| Treatment arm 2 | Active comparator | Subjects will receive LAT. A laser device (Pointer Pulse™) will be used in this study. Receives: Device: Laser auriculotherapy (LAT) |
| Treatment arm 3 | Experimental | Subjects will receive a combined approach that includes the use of LAT plus MAT. LAT will be administered prior to MAT application on the selected auricular points, and the procedures used will be similar to the procedures described for Group 1 and Group 2. Receives: Device: magneto-auriculotherapy (MAT); Device: Laser auriculotherapy (LAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
for collecting data related to the sleep patterns of the subjects. The total score ranges from 0 to 21, with a score greater than five indicating poor sleep quality. Chong and Cheung19 have validated the Cantonese-PSQI and have reported a high internal consistency of 0.75.
Measured: up to 6-month follow up
Secondary outcomes (7)
Sleep latency
Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Sleep latency refers to the length of time it takes from lying down for the night until sleep onset.
Measured: up to 6-month follow up
Wake after sleep onset
Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Wake after sleep onset refers to the amount of time test subjects have spent awake after initially falling asleep and before they awaken for good.
Measured: up to 6-month follow up
Total sleep time
Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Total sleep time refers to the actual sleep time in a sleep episode.
Measured: up to 6-month follow up
Sleep efficiency
Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Sleep efficiency is the ratio of total time spent asleep (total sleep time) in an evening to the total amount of time spent in bed.
Measured: up to 6-month follow up
The Chinese (HK) specific SF-12 v2©
to evaluate the quality of life of the subjects, and has been found to have positive psychometric properties for use in the local population
Measured: up to 6-month follow up
Patient Health Questionnaire
to evaluate the depression status
Measured: up to 6-month follow up
Insomnia Severity Index
to evaluate sleep conditions
Measured: up to 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startMay 2016
- Primary completion31 Jan 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorna Suen, The Hong Kong Polytechnic University
- Investigators
- Lorna Suen, BN, MPH, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970695
- Sponsor's protocol ID
- 13144061
- Status last verified
- Oct 2018
- First submitted
- 17 May 2016
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Suen LKP, Molassiotis A, Yueng SKW, Yeh CH. Comparison of Magnetic Auriculotherapy, Laser Auriculotherapy and Their Combination for Treatment of Insomnia in the Elderly: A Double-Blinded Randomised Trial. Evid Based Complement Alternat Med. 2019 May 21;2019:3651268. doi: 10.1155/2019/3651268. eCollection 2019.
PubMed 31239857
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Auriculotherapy on Older People With Insomnia
- ClinicalTrials.gov ID
- NCT02970695
- Acronym / sponsor ID
- 13144061
- Conditions
- Insomnia
- Keywords
- insomnia, older people, auriculotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 22 Nov 2016 (estimated)
- 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.
Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the improvement of sleep conditions and quality of life on the elders with insomnia.
Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on the improvement of sleep conditions and quality of life in the elderly with insomnia.
Design and subjects This is a 3-arm double-blinded randomised trial. Subjects aged ≥65 and exhibit poor sleep conditions are recruited.
Interventions Group 1: Subjects will receive a deactivated laser treatment followed by MAT. Group 2: Subjects will receive LAT and placebo MAT. Group 3: Subjects will receive a combined approach (LAT plus MAT).
The treatment will be delivered 3 times/week, with a 6-week treatment period, on seven specific auricular points.
Main outcome measures Sleep conditions and quality of life will be evaluated at baseline; end of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods.
Data analysis Descriptive statistics, chi-square analysis, ANOVA, paired t-test, and mixed effect modeling will be conducted as appropriate.
Expected results This study would advance our knowledge the optimum treatment protocol of AT in the improvement of the sleep conditions of the elderly population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment arm 1 | Active comparator | Device: magneto-auriculotherapy (MAT)To achieve a blinding and placebo effect of the subject, the laser device will be switched to "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of MAT. The subjects will be asked to wear a pair of laser protective goggles so as to "blind" them during treatment. |
| Treatment arm 2 | Active comparator | Device: Laser auriculotherapy (LAT)Subjects will receive LAT. A laser device (Pointer Pulse™) will be used in this study. |
| Treatment arm 3 | Experimental | Device: magneto-auriculotherapy (MAT), Device: Laser auriculotherapy (LAT)Subjects will receive a combined approach that includes the use of LAT plus MAT. LAT will be administered prior to MAT application on the selected auricular points, and the procedures used will be similar to the procedures described for Group 1 and Group 2. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Volunteers who are aged 65 or above
- Report having difficulty falling or staying asleep, and/or frequent nocturnal awakenings
- At least three nights per week, sleep disturbance has lasted for a minimum of six months
- Their sleep is of poor quality as indicated by a PSQI score greater than five.
Key exclusion criteria (6 listed)
- profound physical illness, such as stroke
- diagnosed with obstructive sleep apnoea
- having a hearing aid or pacemaker in situ (to prevent the magnetic pellets from interfering with the devices)
- receiving AT within the preceding 6 months,
- suffering from aural injuries or infections, and
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 |
|---|---|---|
| magneto-auriculotherapy (MAT)Subjects will then receive MAT. The magnetic pellets will have ~200 gauss/pellet magnetic flux densities on average, with a diameter of 1.76 mm.The experimental object will be applied to the seven selected acupoints as detected by an acupoint detector. Only one ear will receive treatment at a time, and the pellets will remain in situ for two days before the next change. | Device | Treatment arm 1, Treatment arm 3 |
| Laser auriculotherapy (LAT)A laser device (Pointer Pulse™)15 will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm,2 and a pulse of 10 Hz, which is a common acceptable dosage for clinical use. 16, 17 This application is a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer. A 1-minute treatment using the continuous mode of the device will be directly applied to the selected acupoints. Laser protective goggles will be provided to the subjects and the researcher for eyes protection | Device | Treatment arm 2, Treatment arm 3 |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: up to 6-month follow up
for collecting data related to the sleep patterns of the subjects. The total score ranges from 0 to 21, with a score greater than five indicating poor sleep quality. Chong and Cheung19 have validated the Cantonese-PSQI and have reported a high internal consistency of 0.75.
7 secondary outcomes
Sleep latency
Time frame: up to 6-month follow up
Wake after sleep onset
Time frame: up to 6-month follow up
Total sleep time
Time frame: up to 6-month follow up
Sleep efficiency
Time frame: up to 6-month follow up
The Chinese (HK) specific SF-12 v2©
Time frame: up to 6-month follow up
Patient Health Questionnaire
Time frame: up to 6-month follow up
Insomnia Severity Index
Time frame: up to 6-month follow up
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 18 Oct 2018.
- Derived from this study: PubMed 31239857Suen LKP, Molassiotis A, Yueng SKW, Yeh CH. Comparison of Magnetic Auriculotherapy, Laser Auriculotherapy and Their Combination for Treatment of Insomnia in the Elderly: A Double-Blinded Randomised Trial. Evid Based Complement Alternat Med. 2019 May 21;2019:3651268. doi: 10.1155/2019/3651268. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Lorna Suen, BN, MPH, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magneto-auriculotherapy (MAT) and Laser auriculotherapy (LAT) in people with Insomnia, 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 4 inclusion and 6 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 18 Oct 2018. 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. 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: up to 6-month follow up). 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 NCT02970695, which also lists 1 linked publication.
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 18 Oct 2018.