Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG)
研究概览
简要总结
The aim of this study is to investigate the effects of acupuncture press needle in mild to moderate obstructive sleep apnea patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign inform consent with aged more than 20 years old
- •Mild to moderate OSA, AHI < 30
排除标准
- •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
研究组 & 干预措施
group A (acupuncture press needle)
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.
干预措施: acupuncture press needle (Device)
group B (acupuncture press needle)
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.
干预措施: acupuncture press needle (Device)
结局指标
主要结局
Change of Apnea-Hypopnea Index (AHI) measured by polysomnography (PSG)
时间窗: 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)
时间窗: 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.
次要结局
- 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.)
- Change of snore outcome survey questionnaire (SOS)(change from baseline Snore outcome survey questionnaire (SOS) at 4 weeks and 10 weeks post-treatment)
- 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.)