Apnea, Obstructive SleepNCT04143022
Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients
A study testing acupuncture press needle in people with Apnea, Obstructive Sleep and Snoring, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Apnea, Obstructive Sleep, Snoring
- What is being tested?
- acupuncture press needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Oct 2019to 22 Dec 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign inform consent with aged more than 20 years old
- Mild to moderate OSA, AHI < 30
Who cannot join
- Severe OSA, AHI > 30
- Significant lung disease
- Skeletal facial framework problems
- Central apnea
- Undergone oropharyngeal operations, continuous positive airway pressure or oral devices
- Taking hypnotic drugs
- Pregnancy or breast-feeding
- Receiving acupuncture in recent 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients.
Read the detailed description
Obstructive sleep apnea(OSA) is characterized by multiple episodes of upper airway collapse during sleep and considered as a major health issue worldwide due to comorbidity with obesity, hypertension, diabetes and more advanced cardiovascular diseases. The noisy sounds of snoring caused by OSA bother bed partner sleepless and lead to long-term health problems. Most patients do not tolerate nasal continuous positive airway pressure device, which is the gold standard treatment of OSA. Press needle is one kind of acupuncture which possesses more safety and convenient, few complications and prolonged period of treatment time compared to conventional acupuncture. To date, there is no study to evaluate the effects of press needle in treating OSA. The investigators hypothesize that press needle is effective with high acceptability among OSA patients.
- Conditions
- Apnea, Obstructive Sleep, Snoring
- Being tested
- acupuncture press needle
- Keywords
- acupuncture press needle, obstructive sleep apnea, polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture press needleDevice
Press needle will be applied to acupoints at Jin's 3-tongue point ( EX-HN21 and the two extra channel points, 0.8 individual cun lateral to both sides of EX-HN21) and EX-HN25 in group A and at EX-CA1, EX-CA5 and EX-CA6 in group B. Each subject will start first course and receive the treatment 2 times a week for 4 weeks (8 times in total). Then, it takes 2-week washout period and make group A and group B crossover. Second course begins after 2-week washout period with the same treatment times as the first course.
| Study group | Role | What they receive |
|---|---|---|
| group A (acupuncture press needle) | Active comparator | Group A subjects first receive acupuncture press needle treatment at acupoint of Jin's 3-tongue point and EX-HN25. Then, it takes 2-week washout period. After washout period, subjects receive another course of treatment at acupoint of EX-CA1, EX-CA5 and EX-CA6. Each subject receive 2 times a week of treatment for 4 weeks (8 times in total) in each course. Receives: Device: acupuncture press needle |
| group B (acupuncture press needle) | Active comparator | Group B subjects first receive acupuncture press needle treatment at acupoint of EX-CA1, EX-CA5 and EX-CA6. Then, it takes 2-week washout period. After washout period, subjects receive another course of treatment at acupoint of Jin's 3-tongue point and EX-HN25. Each subject receive 2 times a week of treatment for 4 weeks (8 times in total) in each course. Receives: Device: acupuncture press needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG)
PSG is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine. AHI is calculated by dividing the number of apnea events by the number of hours of sleep.
Measured: change from baseline AHI at 4 weeks and 10 weeks post-treatment
Change of Snore Index (SI) measured by polysomnography (PSG)
PSG is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine. SI is calculated by dividing the number of snore events by the number of hours of sleep.
Measured: change from baseline SI at 4 weeks and 10 weeks post-treatment
Secondary outcomes (3)
Change of snore outcome survey questionnaire (SOS)
The questionnaire used for a patient-based measure for the full range of sleep-disordered breathing patients in whom snoring is a primary symptom, where the goal is to measure the snoring component of sleep-disordered breathing. Total scores are normalized on a scale from 0 to 100. Higher values indicates a better outcome.
Measured: change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment
Change of anti-snore solution record (apnea counts and snore counts)
Anti-snore solution is one kind of smartphone application for recording sleep condition. Apnea counts and sleep counts can be detected by this software.
Measured: This application is applied for every night to record apnea counts and snore counts before treatment and last for 10 weeks.
Change of anti-snore solution record (snore volume)
Anti-snore solution is one kind of smartphone application for recording sleep condition. Snore volume (in dB) can be detected by this software.
Measured: This application is applied for every night to record snore volume before treatment and last for 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start23 Oct 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion22 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, Obstructive SleepStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Crossover
- Model description
- 40 eligible participants diagnosed as mild to moderate OSA will be enrolled and randomly allocated to group A and group B. Press needle will be applied to acupoints at Jin's 3-tongue point ( EX-HN21 and the two extra channel points, 0.8 individual cun lateral to both sides of EX-HN21) and EX-HN25 in group A and at EX-CA1, EX-CA5 and EX-CA6 in group B. Each subject will start first course and receive the treatment 2 times a week for 4 weeks (8 times in total). Then, it takes 2-week washout period and make group A and group B crossover. Second course begins after 2-week washout period with the same treatment times as the first course. The primary outcomes include the apnea-hypopnea index (AHI), snore time, snore index assessed by polysomnography, snore sound assessed by SnoreLab (snore recording and analysis application), and secondary outcome includes snore outcome survey questionnaire (SOS).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143022
- Sponsor's protocol ID
- 201801807A3
- Status last verified
- Jan 2019
- First submitted
- 20 Mar 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. There will be a research number representing the identity. This number will not display the name, identification number, and address. 2. For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential. 3. Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT04143022
- Acronym / sponsor ID
- 201801807A3
- Conditions
- Apnea, Obstructive Sleep, Snoring
- Keywords
- acupuncture press needle, obstructive sleep apnea, polysomnography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 23 Oct 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 22 Dec 2020 (estimated)
- First posted
- 29 Oct 2019 (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 aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients.
Detailed description
Obstructive sleep apnea(OSA) is characterized by multiple episodes of upper airway collapse during sleep and considered as a major health issue worldwide due to comorbidity with obesity, hypertension, diabetes and more advanced cardiovascular diseases. The noisy sounds of snoring caused by OSA bother bed partner sleepless and lead to long-term health problems. Most patients do not tolerate nasal continuous positive airway pressure device, which is the gold standard treatment of OSA. Press needle is one kind of acupuncture which possesses more safety and convenient, few complications and prolonged period of treatment time compared to conventional acupuncture. To date, there is no study to evaluate the effects of press needle in treating OSA. The investigators hypothesize that press needle is effective with high acceptability among OSA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 40 eligible participants diagnosed as mild to moderate OSA will be enrolled and randomly allocated to group A and group B. Press needle will be applied to acupoints at Jin's 3-tongue point ( EX-HN21 and the two extra channel points, 0.8 individual cun lateral to both sides of EX-HN21) and EX-HN25 in group A and at EX-CA1, EX-CA5 and EX-CA6 in group B. Each subject will start first course and receive the treatment 2 times a week for 4 weeks (8 times in total). Then, it takes 2-week washout period and make group A and group B crossover. Second course begins after 2-week washout period with the same treatment times as the first course. The primary outcomes include the apnea-hypopnea index (AHI), snore time, snore index assessed by polysomnography, snore sound assessed by SnoreLab (snore recording and analysis application), and secondary outcome includes snore outcome survey questionnaire (SOS).
| Arm | Type | Receives |
|---|---|---|
| group A (acupuncture press needle) | Active comparator | Device: acupuncture press needleGroup A subjects first receive acupuncture press needle treatment at acupoint of Jin's 3-tongue point and EX-HN25. Then, it takes 2-week washout period. After washout period, subjects receive another course of treatment at acupoint of EX-CA1, EX-CA5 and EX-CA6. Each subject receive 2 times a week of treatment for 4 weeks (8 times in total) in each course. |
| group B (acupuncture press needle) | Active comparator | Device: acupuncture press needleGroup B subjects first receive acupuncture press needle treatment at acupoint of EX-CA1, EX-CA5 and EX-CA6. Then, it takes 2-week washout period. After washout period, subjects receive another course of treatment at acupoint of Jin's 3-tongue point and EX-HN25. Each subject receive 2 times a week of treatment for 4 weeks (8 times in total) in each course. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing to sign inform consent with aged more than 20 years old
- Mild to moderate OSA, AHI < 30
Key exclusion criteria (8 listed)
- Severe OSA, AHI > 30
- Significant lung disease
- Skeletal facial framework problems
- Central apnea
- Undergone oropharyngeal operations, continuous positive airway pressure or oral devices
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 |
|---|---|---|
| acupuncture press needlePress needle will be applied to acupoints at Jin's 3-tongue point ( EX-HN21 and the two extra channel points, 0.8 individual cun lateral to both sides of EX-HN21) and EX-HN25 in group A and at EX-CA1, EX-CA5 and EX-CA6 in group B. Each subject will start first course and receive the treatment 2 times a week for 4 weeks (8 times in total). Then, it takes 2-week washout period and make group A and group B crossover. Second course begins after 2-week washout period with the same treatment times as the first course. | Device | group A (acupuncture press needle), group B (acupuncture press needle) |
Primary outcome
Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG)
Time frame: change from baseline AHI at 4 weeks and 10 weeks post-treatment
PSG is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine. AHI is calculated by dividing the number of apnea events by the number of hours of sleep.
Change of Snore Index (SI) measured by polysomnography (PSG)
Time frame: change from baseline SI at 4 weeks and 10 weeks post-treatment
PSG is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine. SI is calculated by dividing the number of snore events by the number of hours of sleep.
3 secondary outcomes
Change of snore outcome survey questionnaire (SOS)
Time frame: change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment
Change of anti-snore solution record (apnea counts and snore counts)
Time frame: This application is applied for every night to record apnea counts and snore counts before treatment and last for 10 weeks.
Change of anti-snore solution record (snore volume)
Time frame: This application is applied for every night to record snore volume before treatment and last for 10 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No. 1. There will be a research number representing the identity. This number will not display the name, identification number, and address. 2. For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential. 3. Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture press needle in people with Apnea, Obstructive Sleep and Snoring, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 8 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: status not confirmed, as of the sponsor's last update on 29 Oct 2019. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YUAN-CHIEH YEH, Doctor (24313131 ext. 2127, b9005030@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG) (time frame: change from baseline AHI at 4 weeks and 10 weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2019.