Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Health-related quality of life: SF-36
研究概览
简要总结
This study evaluates the addition of a comprehensive lifestyle program including dietary management and exercise to continuous positive airway pressure (CPAP) therapy in overweighted adults with obstructive sleep apnea. Half of the participants will receive CPAP therapy while the other half will have diet consultations, nordic walking sessions and CPAP.
详细描述
While the specific impact of obstructive sleep apnea (OSA) on quality of life is well established, the impact of CPAP therapy on quality of life remains unclear. Yet, improving the quality of life of OSA patient is one of the main targets of treatment.
Both exercise and healthy diet are recommended in the management of overweight and obesity. This should improve quality of life as well as comorbidities associated with sleep apnea.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly diagnosed for obstructive sleep apnea and requiring CPAP therapy
- •BMI>25and≤40kg/m2
- •Low physical activity (< 150 min of MVPA per week)
- •Able to give informed consent as documented by signature
排除标准
- •Patients already treated for OSA or another sleep disorder
- •Required use of supplemental oxygen
- •Active infection, malignancy or chronic inflammatory disorders
- •More than moderate alcohol use of > 14 drinks per week
- •Severe depression defined by a BDI > 30
- •Surgery within the previous 3 months
- •Known cardiac or pulmonary disease contraindicating exercise training
- •Patient with a bariatric surgery project or already operated
- •Pregnant or lactating women
- •Onset of a severe cardiac disease contraindicating exercise training
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, peripheral functional limitation.
结局指标
主要结局
Health-related quality of life: SF-36
时间窗: 12 weeks
Mean difference in the general health perception (GH) domain on the Medical Outcome Study Short Form (SF-36) between groups
次要结局
- Hip circumference(12 and 24 weeks)
- Waist-hip ratio(12 and 24 weeks)
- Neck size(12 and 24 weeks)
- Weight(12 and 24 weeks)
- Blood pressure(12 and 24 weeks)
- Concentration of fasting glucose(12 and 24 weeks)
- Concentration of insulin(12 and 24 weeks)
- Autonomic Arousal Area under the curve(12 and 24 weeks)
- Autonomic Arousal duration(12 and 24 weeks)
- Exercise capacity(12 and 24 weeks)
- General quality of life: SF-36(12 and 24 weeks)
- Specific quality of life: Calgary Sleep Apnea Quality of Life Index (SAQLI)(12 and 24 weeks)
- Height(12 and 24 weeks)
- Daytime excessive sleepiness(12 and 24 weeks)
- Subjective sleep quality(12 and 24 weeks)
- Mood(12 and 24 weeks)
- Body-mass index (BMI)(12 and 24 weeks)
- Waist circumference(12 and 24 weeks)
- Rate of glycosylated haemoglobin(12 and 24 weeks)
- Concentration of triglycerides(12 and 24 weeks)
- Respiratory events(12 and 24 weeks)
- Desaturation events(12 and 24 weeks)
- Autonomic Arousal Index (Aai)(12 and 24 weeks)
- CPAP withdrawal(12 and 24 weeks)
- Postural stability(12 and 24 weeks)
- Depression(12 and 24 weeks)
- Fatigue(12 and 24 weeks)
- Fat distribution(12 and 24 weeks)
- Concentration of ultrasensible CRP(12 and 24 weeks)
- Nocturnal hypoxic load(12 and 24 weeks)
- CPAP compliance(12 and 24 weeks)
- Moderate to vigorous physical activity(12 and 24 weeks)
- Light physical activity (LPA) behaviour(12 and 24 weeks)
- Concentration of total cholesterol(12 and 24 weeks)
- Concentration of LDL cholesterol(12 and 24 weeks)
- Sedentary behaviour(12 and 24 weeks)
- Resting metabolism(12 and 24 weeks)
- Concentration of HDL cholesterol(12 and 24 weeks)
- T90%(12 and 24 weeks)
- CPAP adherence(12 and 24 weeks)
- Medical visit(12 and 24 weeks)
研究者
Raphael Heinzer
Prof.
Centre Hospitalier Universitaire Vaudois