m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome. Prospective, Randomized, Controlled, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change from baseline daytime sleepness at 6 months
研究概览
简要总结
Obstructive sleep apnea syndrome (OSA) is a common condition associated with major repercussions such as excessive daytime sleepiness and impaired quality of life as well as metabolic and cardiovascular complications. Continuous positive airway pressure (CPAP) remains the treatment of choice but its effectiveness remains limited, especially in reducing cardio-metabolic risk. Interventions to modify the lifestyle are therefore recommended in the management of OSA. The emergence of information and communication technologies is an opportunity for patients to have tools that promote self-management and behavioral changes. The recent development of telerehabilitation (TR) is a promising approach that has only been the subject of pilot studies. In a randomized, controlled and multicenter study, we propose to test the hypothesis according to which the use of a mobile TR solution, associated with continuous positive airway pressure (CPAP), will allow obese patients to adopt behavioral modifications to improve markers of severity of OSA. The analysis of big data (data-mining) will allow a better understanding of the motivational obstacles and levers.
详细描述
Statistical analysis plan The number of patients solicited for the study and the number of subjects included and randomized in each group will be reported on the flow chart. Premature stops (lost to follow-up, death, study withdrawals) and their reasons will be reported as well as any deviations from the protocol.
An initial descriptive analysis of each of the groups will be carried out. For qualitative variables, this description will include the number as well as the frequency of the different modalities. Concerning the quantitative variables, the description will include the number, the mean, the standard deviation, the median as well as the extreme values according to the distribution.
The comparability of the 2 groups will be verified for all the initial characteristics likely to influence the results. In the event of non-comparability on one or more parameters, an adjustment will be made on this or these parameters for the comparisons between groups of judgment criteria.
Analysis of the primary judgment criterion The variation in the evolution of the various main criteria will be compared between the 2 groups using a nonparametric means comparison test (Mann-Whitney test) or if the distribution turns out to be Gaussian and the conditions application are verified, a parametric test (Student's T).
Analysis of secondary endpoints The qualitative variables will be compared by a Chi-square test. Otherwise, if the conditions for performing this test are not met, Fisher's exact test will be used.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe obstructive sleep apnea (apnea-hypopnea index ≥30 / hour)
- •Body mass index ≥ 30 kg / m²
- •age between 30 and 75 years old
- •written consent
排除标准
- •Presence of contraindications to perform exercise training (neuromuscular disease, orthopedic cause, acute coronary syndrome or stroke in the previous three months)
- •Active infection, chronic inflammatory disease, cancer under treatment. Systemic treatment with immunosuppressants or corticosteroids
- •Obstructive Sleep Apnea treated by Continuous Positive Airway Pressure or mandibular advancement device in the 3 months preceding inclusion
- •Participation in a rehabilitation program scheduled within six months of inclusion
- •Predominantly central sleep apnea syndrome (AC> 50%)
- •Heart failure with Left Ventricular Ejection Fraction <40% known
- •Bariatric surgery in the previous 6 months or bariatric surgery project in the 6 months
- •Alcohol> 14 drinks per week
- •Inability to understand and / or answer questionnaires.
- •Refusal to use a smartphone or digital device
- •Inability to access an internet connection at home.
- •Subject in a period of relative exclusion with respect to another protocol or for which the maximum annual amount of compensation of € 4,500 has been reached.
- •Subject not affiliated with a social security scheme, or not beneficiary of such a scheme.
- •Pregnant or breastfeeding woman, patient unable to give her protected adult consent, vulnerable people
- •Subject deprived of liberty by judicial or administrative decision
研究组 & 干预措施
Experimental arm
Patients in the experimental group will be treated with CPAP (PRISMA, LOWENSTEIN®) and will have access to the m-Rehab® telerehabilitation program.
干预措施: Telerehabilitation solution (m-Rehab) (Other)
Control arm
Patients in the experimental group will be treated with CPAP (PRISMA, LOWENSTEIN) and will receive the usual advice on adapted physical activity and nutrition during the initial consultation.
结局指标
主要结局
Change from baseline daytime sleepness at 6 months
时间窗: Between baseline and 6 month visit
Epworth questionnaire
Change from baseline inflammation at 6 months
时间窗: Between baseline and 6 month visit
C-reactive protein in blood
Change from baseline quality of life at 6 months
时间窗: Between baseline and 6 month visit
Functional Outcomes of Sleep Questionnaire (FOSQ)
Change from baseline systolic blood pressure at 6 months
时间窗: Between baseline and 6 month visit
Blood pressure : nocturnal systolic BP (ambulatory blood pressure measurement)
次要结局
- Evolution of quality of life in experimental and control group(Between inclusion and 6 month visit)
- Evolution of sleepiness in experimental and control group (Epworth)(Between inclusion and 6 month visit)
- Evolution of anxiety and depression in experimental and control group with Hospital Anxiety and Depression scale(Between inclusion and 6 month visit)
- Evolution of biological parameters in experimental and control group (glycated haemoglobin (HbA1c))(Between inclusion and 6 month visit)
- Evolution of fatigue in experimental and control group(Between inclusion and 6 month visit)
- Evolution of sleepiness in experimental and control group (IHSS)(Between inclusion and 6 month visit)
- Evolution of polysomnographic markers in experimental and control group(Between inclusion and 6 month visit)
- Evolution of physical activity parameters in experimental and control group (IPAQ)(Between inclusion and 6 month visit)
- Evolution of anthropometric parameters in experimental and control group(Between inclusion and 6 month visit)
- Evolution of biological parameters in experimental and control group (HDL cholesterol)(Between inclusion and 6 month visit)
- Evolution of sleep quality in experimental and control group(Between inclusion and 6 month visit)
- Evolution of sleepiness in experimental and control group (iterative sleep latency tests)(Between inclusion and 6 month visit)
- Evolution of physical activity parameters in experimental and control group (actimetry)(Between inclusion and 6 month visit)
- Evolution of nutritional parameters in experimental and control group(Between inclusion and 6 month visit)
- Assessment of device-related factors influencing CPAP adherence in experimental and control group(Between inclusion and 6 month visit)
- Evolution of biological parameters in experimental and control group (total cholesterol)(Between inclusion and 6 month visit)
- Evolution of biological parameters in experimental and control group (LDL cholesterol)(Between inclusion and 6 month visit)
- Evolution of biological parameters in experimental and control group (triglycerides)(Between inclusion and 6 month visit)
- Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group(Between inclusion and 1 month visit)
- Assessment of the incremental cost-utility ratio in experimental and control group(At 6 month visit)
- Evolution of the architecture of sleep in experimental and control group(Between inclusion and 6 month visit)
- Evolution of exercise tolerance in experimental and control group(Between inclusion and 6 month visit)
- Evolution of biological parameters in experimental and control group (fasting blood sugar)(Between inclusion and 6 month visit)
- Evolution of blood pressure profile parameters in experimental and control group(Between inclusion and 6 month visit)
- Assessment of individual factors influencing CPAP adherence in experimental and control group(Between inclusion and 6 month visit)
- Evolution of endothelial function in experimental and control group(Between inclusion and 6 month visit)