Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients
- Conditions
- Apnea, Obstructive SleepSnoring
- Registration Number
- NCT04143022
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Willing to sign inform consent with aged more than 20 years old
- Mild to moderate OSA, AHI < 30
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG) 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) 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.
- Secondary Outcome Measures
Name Time Method Change of anti-snore solution record (apnea counts and snore counts) This application is applied for every night to record apnea counts and snore counts before treatment and last for 10 weeks. Anti-snore solution is one kind of smartphone application for recording sleep condition. Apnea counts and sleep counts can be detected by this software.
Change of snore outcome survey questionnaire (SOS) change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment 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 of anti-snore solution record (snore volume) This application is applied for every night to record snore volume before treatment and last for 10 weeks. Anti-snore solution is one kind of smartphone application for recording sleep condition. Snore volume (in dB) can be detected by this software.
Trial Locations
- Locations (1)
Keelung Chang Gung Memorial Hospital
🇨🇳Keelung, Taiwan
Keelung Chang Gung Memorial Hospital🇨🇳Keelung, Taiwan