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)
Apnée+6
+ Maladies du système nerveux
+ Troubles respiratoires
Étude thérapeutique
Résumé
Date de début de l'étude : 27 septembre 2021
Date à laquelle le premier participant a commencé l'étude.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
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.180 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 30 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site