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The aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture press needle | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | change from baseline SI at 4 weeks and 10 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YUAN-CHIEH YEH, Doctor | Contact | 24313131 | 2127 | b9005030@gmail.com |
| YI-HSIEN SHIAO, Doctor | Contact | 24313131 | 2127 | vincentking44@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung Memorial Hospital | Keelung | 20401 | Taiwan |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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).
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| 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. | 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. | This application is applied for every night to record snore volume before treatment and last for 10 weeks. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |