Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.
详细描述
For patients with moderate OSAS, with few or no symptoms, without associated cardiovascular comorbidities, there is no recommended treatment. Rehabilitate the inspiratory and oropharyngeal muscles through muscle strengthening seems to be an alternative to this problem. Therefore, this study proposes a complete rehabilitation care evaluating the effectiveness of the strengthening of inspiratory and oropharyngeal muscles in subject with moderate OSAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Moderate SAHOS (15 ≤ AHI ≤30);
- •Body Mass Index (BMI) < 35 ;
- •Patient affiliated or entitled to a social security scheme;
- •Patient having signed a consent to participate in the study.
排除标准
- •Excessive daytime sleepiness: Epworth sleepiness score > 10 ;
- •Professional driving and history of accidents related to sleepiness;
- •Severe obstructive or restrictive ventilatory disorders of neuromuscular origin authenticated by respiratory function tests;
- •Patients undergoing treatment for OSAS or requiring immediate initiation of continuous positive airway pressure (CPAP) or a mandibular advancement orthosis;
- •Patients who have stopped CPAP or orthosis treatment in less than one month;
- •Patients undergoing cardiorespiratory exercise rehabilitation or starting regular physical training;
- •Uncompensated heart failure, thoracic sternotomy surgery < 4 months;
- •Marked osteoporosis with history of rib fractures;
- •History of spontaneous pneumothorax;
- •Severe asthma;
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: At 3 months
AHI is measured by polygraphy or polysomnography. It is not a score
次要结局
- Maximum inspiratory pressure measurement (cmH2O)(At 3 and 9 Months)
- Neck circumference (cm)(At 3 months)
- Epworth sleepiness score(At 3 and 9 Months)
- Pittsburgh Sleep quality index(At 3 and 9 Months)
- Quality of life scale : Short Form 12 (SF12)(At 3 and 9 Months)
- PICOT fatigue scale(At 3 and 9 Months)
- AHI (Apnea-Hypopnea Index)(At 9 months)