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.
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. The quantitative variables will be compared between the two groups: * in the case of Gaussian variables, by a student's t test or an analysis of variance * in the case of non-Gaussian variables, by a Wilcoxon-Mann-Withney test Longitudinal data (quality of life scores, physical activities) will be modeled by a mixed regression with the patient effect as a random variable. A linear regression model modeling the variation of the longitudinal endpoints will be fitted to the covariates having at least one trend (p \<0.15) to the difference between the two arms of the study. A forward type procedure will be implemented to obtain a final multivariate model. Management of missing data: The IPTW method will be used. The lost to follow-up will be considered using a weighting on the inverse of the probability of being censored
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
The telerehabilitation program consists of the following elements: * Mobile applications and website usable on smartphone and tablet for the patient. * Teleconsultation solution for the patient and the doctors. * Video conferencing solution for professionals involved in patient follow-up: educators in adapted physical activity, physiotherapists, psychologists, dieticians, etc. * Web interface for health professionals allowing the collection and monitoring of various parameters in physical activity and nutrition as well as progress in therapeutic education activities. * Withings® connected objects
CHU Montpellier
Montpellier, France
Change from baseline daytime sleepness at 6 months
Epworth questionnaire
Time frame: Between baseline and 6 month visit
Change from baseline quality of life at 6 months
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: Between baseline and 6 month visit
Change from baseline systolic blood pressure at 6 months
Blood pressure : nocturnal systolic BP (ambulatory blood pressure measurement)
Time frame: Between baseline and 6 month visit
Change from baseline inflammation at 6 months
C-reactive protein in blood
Time frame: Between baseline and 6 month visit
Evolution of fatigue in experimental and control group
Pichot questionnaire
Time frame: Between inclusion and 6 month visit
Evolution of quality of life in experimental and control group
EQ5D (EuroQol) questionnaire
Time frame: Between inclusion and 6 month visit
Evolution of sleep quality in experimental and control group
Pittsburg questionnaire
Time frame: Between inclusion and 6 month visit
Evolution of anxiety and depression in experimental and control group with Hospital Anxiety and Depression scale
Anxiety and depression will be evaluated with the HAD (Hospital Anxiety and Depression) scale (values 0-21 with higher score meaning a worse outcome).
Time frame: Between inclusion and 6 month visit
Evolution of sleepiness in experimental and control group (Epworth)
Percentage of patients with Epworth fall\> 2
Time frame: Between inclusion and 6 month visit
Evolution of sleepiness in experimental and control group (IHSS)
Assessed by the Idiopathic Hypersomnia Severity Scale. The total score is 0 to 50 with a higher score indicating more drowsiness.
Time frame: Between inclusion and 6 month visit
Evolution of sleepiness in experimental and control group (iterative sleep latency tests)
Evaluated by iterative sleep latency tests
Time frame: Between inclusion and 6 month visit
Evolution of the architecture of sleep in experimental and control group
Architecture of sleep will be evaluated with polysomnography : Stages of sleep (Stages N1 N2, N3 and REM in minutes and %), sleep efficiency (%), micro-arousal index (number of events/hour)
Time frame: Between inclusion and 6 month visit
Evolution of polysomnographic markers in experimental and control group
time spent under a SpO2 of 90%
Time frame: Between inclusion and 6 month visit
Evolution of physical activity parameters in experimental and control group (IPAQ)
evaluated by International Physical Activity Questionnaire (IPAQ)
Time frame: Between inclusion and 6 month visit
Evolution of physical activity parameters in experimental and control group (actimetry)
evaluated by actimetry (number of steps)
Time frame: Between inclusion and 6 month visit
Evolution of nutritional parameters in experimental and control group
assessed by dietary calendar
Time frame: Between inclusion and 6 month visit
Evolution of exercise tolerance in experimental and control group
assessed by exercise test on a cycloergometer
Time frame: Between inclusion and 6 month visit
Evolution of anthropometric parameters in experimental and control group
ratio of waist circumference to hip circumference
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (fasting blood sugar)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (total cholesterol)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (LDL cholesterol)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (HDL cholesterol)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (triglycerides)
Time frame: Between inclusion and 6 month visit
Evolution of biological parameters in experimental and control group (glycated haemoglobin (HbA1c))
Time frame: Between inclusion and 6 month visit
Evolution of endothelial function in experimental and control group
assessed by endoPAT
Time frame: Between inclusion and 6 month visit
Evolution of blood pressure profile parameters in experimental and control group
evaluated by ambulatory blood pressure measurement over 24 hours
Time frame: Between inclusion and 6 month visit
Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group
Time frame: Between inclusion and 6 month visit
Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group
Time frame: Between inclusion and 3 month visit
Evolution of adherence to Continuous positive airway pressure (CPAP) in experimental and control group
Time frame: Between inclusion and 1 month visit
Assessment of individual factors influencing CPAP adherence in experimental and control group
The individual factors studied are gender, body mass index and age.
Time frame: Between inclusion and 6 month visit
Assessment of device-related factors influencing CPAP adherence in experimental and control group
The device-related factors are are the type of mask, fixed or autopilot mode and whether or not a humidifier is used. The factors of the CPAP are: residual IAH (number/hour), the pressure P90 (cmH2O), the leaks (% and liter/minute), the duration of deep sleep (minutes and %) evaluated by the CPAP.
Time frame: Between inclusion and 6 month visit
Assessment of the incremental cost-utility ratio in experimental and control group
Time frame: At 6 month visit
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