Strategies for Controlling Unintentional Leakage in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 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 A will consist of a cross-over controlled randomized trial to compare unintentional leak during auto-CPAP and during fixed CPAP after the progressive reduction of fixed CPAP, starting at the 90 th percentile obtained during a period of auto-CPAP. The order of interventions will be randomized. Auto-CPAP with a nasal mask will be used for 7 days. In the fixed CPAP arm, CPAP will be progressively reduced over a period of up to 21 days until leak is controlled or residual apnea-hypopnea index increases over 10 events/h. Subjects that persisted with excessive leak at the end of the Study A will be invited to Study B.
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
- Single (Participant)
盲法说明
CPAP device screen is taped to hide CPAP level and mode
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 leak line drop events
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
- CPAP Side-effects questionnaire(27 days)
研究者
Pedro Rodrigues Genta
Principal Investigator
University of Sao Paulo General Hospital