Evaluation of Treatment Effect of Cervical Collar in Moderate Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in Apnea Hypopnea Index (AHI) measured at baseline and after 6+/- 2 weeks of treatment.
研究概览
简要总结
This study evaluates treatment effect of Cervical Collar (CC) in moderate obstructive sleep apnea.The investigators believe that stabilization of the neck by using a CC during sleep helps sustain airway patency. This would mean preventing collapse of airways during sleep.
The study is a randomized, open, parallel-group intervention study. The two treatment groups are:
A. Patients with moderate OSA are treated with lifestyle advice (n = 50) B. Patients with moderate OSA are treated with CC and lifestyle advice (n = 50).
详细描述
Moderate and severe obstructive sleep apnea (OSA) is strongly associated with cardiovascular diseases, diabetes and also with occupational and traffic accidents due to fatigue and daytime sleepiness. Treatment of moderate OSA is usually by a mandibular advancement device (MAD) and in sometimes even Continuous Positive Airway Pressure (CPAP). MAD and CPAP treatment effectiveness is impeded by limited compliance with long term treatment. Knowledge about mechanical barriers in upper respiratory tract has triggered interest in finding a new treatment method that may prevent collapse of airways during sleep. The investigators believe that stabilization of the neck by using a cervical collar (CC) during sleep helps sustain airway patency. This would mean improved oxygen saturation in the blood and a reduction of daytime fatigue in patients with OSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate obstructive sleep apnea (AHI 15-30)
- •Age 18-75
- •Signed Informed Consent
排除标准
- •Ongoing or planned pregnancy during intervention
- •Whiplash injury or other neck pain
- •Rheumatic diseases
- •Active alcohol or drug abuse <2 back in time
- •Treatment with sleeping pills or other sedatives
- •Cannot wear CC for any reason
- •Pregnant or lactating women
- •Not expected to be able to comply with nighttime breathing registration/treatment due to medical and/or psychological conditions.
结局指标
主要结局
Changes in Apnea Hypopnea Index (AHI) measured at baseline and after 6+/- 2 weeks of treatment.
时间窗: 6+/- 2 weeks of treatment.
The definition of AHI is the sum of apneas and hypopneas divided by registration/sleep time. Se below description of Apnea and Hypopnea. According to the international classification of sleep disorders, mild Obstructive Sleep Apnae (OSA) is defined as AHI between 5-15, moderate as AHI between 15-30 and severe sleep apnea as AHI \> 30.
次要结局
未报告次要终点