Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AHI Variation
研究概览
简要总结
Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality (RR = 9.1 [95%, 2.6 to 31.2]).
If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30) may be too demanding. Alternative treatments are rare and results are highly variable. Therefore, it would be interesting to suggest other treatment modalities with moderate coronary and/or minimally symptomatic OSA syndrome.
详细描述
This study aims to assess the relevance of inspiratory muscles strengthening on reducing AHI in CAD patients with moderate OSA (AHI between 15 and 30).
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate OSA (15 <AHI <30)
- •Period between acute coronary syndrome and inclusion <60 days
- •Patients included in cardiac rehabilitation
排除标准
- •Obstructive lung disease with Tiffeneau index less than 70%.
- •Restrictive lung disease with a reduction of total lung capacity (TLC)
- •Treatment for OSA or clinical context (comorbidity) justifying CPAP
- •Congestive heart failure, thoracic surgery by sternotomy
- •Spontaneous pneumothorax
- •Severe Asthma
- •Ruptured eardrum, or another disease of the middle ear, or acute sinusitis
研究组 & 干预措施
Inspiratory muscles strengthening
The device used is : POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK).
Class I, CE labelled. POWERbreathe fitness Plus uses the technique of training against resistance to increase the strength, the power and the endurance of the respiratory muscles (diaphragm and rib cage).
干预措施: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening] (Device)
Control
No intervention
干预措施: Control (Other)
结局指标
主要结局
AHI Variation
时间窗: At 6 weeks
It is the difference between the AHI at the inclusion et the AHI at 6 weeks
次要结局
- Circumference of the neck in centimetre(At 6 weeks)
- Epworth questionnaire to evaluate the deficit of sleep(at 6 weeks)
- Pittsburgh questionnaire to evaluate the quality of sleep(At 6 weeks)
- SF12 questionnaire to evaluate the quality of life(At 6 weeks)