Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 95th CPAP unintentional leak
研究概览
简要总结
Oral unintentional leak is a common side effect of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies. Higher levels of CPAP are associated with higher leak. In the present study, a sequential approach to control excessive unintentional leak will be tested. In study A, the reduction of therapeutic CPAP level will be tested. In study B, oronasal CPAP will be compared to nasal CPAP with a chinstrap.
详细描述
Study B will consist of a controlled crossover trial to compare unintentional leak during the use of an oronasal mask versus a nasal mask with a chinstrap, among subjects who remain with excessive leak at the end of study A. The order of interventions will be randomized. One of the groups will initially use an oronasal mask for 10 days. A washout period of 7 days under nasal CPAP will follow. After washout, subjects will continue using a nasal mask and will be asked to use a chinstrap for another 10 days. In the other group, the order of interventions will be the opposite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Diagnosis of moderate and severe obstructive sleep apnea;
- •Use of CPAP with a nasal mask;
- •95th percentile of unintentional leak from the last 7 days above 24 l/min, or at least 4 sudden drops of leak over one night of nasal CPAP
- •Persistence of excessive leak at the end of Study A.
排除标准
- •Patients who experience unintentional leakage from the mask/accessories.
- •Diagnostic polysomnography examination with a predominance of central apnea;
- •Patients with unstable heart disease, bedridden, neurodegenerative diseases, severe psychiatric disorders and COPD;
- •Previous surgery for obstructive sleep apnea;
- •Severe nasal obstruction (NOSE questionnaire score equal or greater then 55 points).
结局指标
主要结局
95th CPAP unintentional leak
时间窗: 27 days
The 95th unintentional leak percentile value will be compared during both interventions
次要结局
- Residual apnea-hypopnea index (AHI)(27 days)
- CPAP Side-effects questionnaire(27 days)
- Functional Outcomes of Sleep Questionnaire (FOSQ 10)(27 days)
- Pittsburgh questionnaire(27 days)
研究者
Pedro Rodrigues Genta
Principal Investigator
University of Sao Paulo General Hospital