mRehabOSAm-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome. Prospective, Randomized, Controlled, Multicenter Study
Telerehabilitation solution (m-Rehab)
Apnea+6
+ Nervous System Diseases
+ Respiration Disorders
Treatment Study
Summary
Study start date: September 27, 2021
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.180 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Severe obstructive sleep apnea (apnea-hypopnea index ≥30 / hour) * Body mass index ≥ 30 kg / m² * age between 30 and 75 years old * written consent Exclusion Criteria: * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location