Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- CPAP compliance
研究概览
简要总结
CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.
详细描述
Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.
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
- None
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
- •normal nasal breathing
- •dentition allowing for use of an oral appliance
- •absence of mandibular joint pathology
- •Patients requiring the use of a facial mask during CAPP titration due to presence of mouth leaks with a nasal/prong interface
- •Patients using CPAP less than 3 hours/day as prescribed following CPAP titration
排除标准
- •Clinical instability
- •smoking cessation
- •current weight loss strategy
- •Marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy)
- •severe cardio-metabolic co-morbidity
结局指标
主要结局
CPAP compliance
时间窗: After 4 weeks of CPAP trial
CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition.
次要结局
- diurnal somnolence(After 4 weeks of CPAP trial)
研究者
Frédéric Sériès
Director IUCPQ sleep laboratory
Laval University