Oral Appliance in the Treatment of Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing the Efficacy of Two Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 313
- 试验地点
- 4
- 主要终点
- Apnoea-Hypopnea-Index (AHI)
研究概览
简要总结
The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same. The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment and the cost of treatment during one year.
This randomized controlled parallel group multicenter study includes 316 subjects referred for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit the clinic at 5 scheduled occasions.
详细描述
The study includes 2 arms. Secondary measures are obtained by respiratory analysis and questionnaires. Electromyography (EMG) of the masseter muscle is recorded and the influence of bruxism is evaluated in terms effect on efficacy and adverse events
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of obstructive sleep apnea with AHI > 15
- •Odontological status that allows retention of oral devices and with at least one molar in each quadrant
- •Maximal protrusion >6 mm
- •Subject giving his/her informed concent
- •Understands and can communicate in Swedish
- •Subject understands the instruction on how to put on the polygraphy equipment at home
- •Valid AHI data at baseline respiratory analysis
排除标准
- •age< 18 år
- •Jaw complaints requiring treatment the past year
- •Pain or locking of the jaw at the enrollment visit
- •At the discretion of the investigator judged not being able to attach to the study directives
- •Hypersensitive to the material of the devices
- •Ongoing Continuous Positive Airway Pressure (CPAP) treatment or oral device treatment or such treatment terminated within a month from enrollment
结局指标
主要结局
Apnoea-Hypopnea-Index (AHI)
时间窗: 9 weeks after start of study
AHI defined by American Academy of Sleep Medicine (AASM)
次要结局
- Adverse events(1 year)
- Sleepiness(9 weeks and 1 year)
- Oxygen Desaturation Index (ODI)(9 weeks)
- Quality of life(9 weeks and 1 year)
- Sleep bruxism(9 weeks)