m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome
Key facts
- Who runs it
- University Hospital, Montpellier
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 180 people enrolled
- Started
- 27 Sept 2021
- Ended
- 5 Jun 2024
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Telerehabilitation solution (m-Rehab)
- Record updated
- 12 June 2026
Who can take part
- Age
- 30 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Severe obstructive sleep apnea (apnea-hypopnea index ≥30 / hour)
- Body mass index ≥ 30 kg / m²
- age between 30 and 75 years old
- written consent
Who cannot take part
- 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
- Bariatric surgery in the previous 6 months or bariatric surgery project in the 6 months
- Predominantly central sleep apnea syndrome (AC> 50%)
- Heart failure with Left Ventricular Ejection Fraction <40% known
- 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
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Experimental armTreatment being tested
Patients in the experimental group will be treated with CPAP (PRISMA, LOWENSTEIN®) and will have access to the m-Rehab® telerehabilitation program.
Treatment: Telerehabilitation solution (m-Rehab)
- Control armNo study treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome. Prospective, Randomized, Controlled, Multicenter Study
- Record updated
- 12 June 2026