m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome

NCT05049928 | Completed

• 2 other identifiers: RECHMPL19_00622020-A02100-39
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (4)

• Change from baseline daytime sleepness at 6 months

  Epworth questionnaire

  Between baseline and 6 month visit

• Change from baseline quality of life at 6 months

  Functional Outcomes of Sleep Questionnaire (FOSQ)

  Between baseline and 6 month visit

• Change from baseline systolic blood pressure at 6 months

  Blood pressure : nocturnal systolic BP (ambulatory blood pressure measurement)

  Between baseline and 6 month visit

• Change from baseline inflammation at 6 months

  C-reactive protein in blood

  Between baseline and 6 month visit

Secondary Outcomes (28)

• Evolution of fatigue in experimental and control group

  Between inclusion and 6 month visit

• Evolution of quality of life in experimental and control group

  Between inclusion and 6 month visit

• Evolution of sleep quality in experimental and control group

  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 sleepiness in experimental and control group (Epworth)

  Between inclusion and 6 month visit

Study Arms (2)

Experimental arm

EXPERIMENTAL

Patients in the experimental group will be treated with CPAP (PRISMA, LOWENSTEIN®) and will have access to the m-Rehab® telerehabilitation program.

Other: Telerehabilitation solution (m-Rehab)

Control arm

NO INTERVENTION

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.

Interventions

Telerehabilitation solution (m-Rehab) OTHER

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

Experimental arm

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe obstructive sleep apnea (apnea-hypopnea index ≥30 / hour)
• Body mass index ≥ 30 kg / m²
• age between 30 and 75 years old
• written consent

You may not qualify if:

• 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
• 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 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34080, France

Location

Related Publications (1)

• Bughin F, Mendelson M, Jaffuel D, Pepin JL, Gagnadoux F, Goutorbe F, Abril B, Ayoub B, Aranda A, Alagha K, Pomies P, Roubille F, Mercier J, Molinari N, Dauvilliers Y, Heraud N, Hayot M. Impact of a telerehabilitation programme combined with continuous positive airway pressure on symptoms and cardiometabolic risk factors in obstructive sleep apnea patients. Digit Health. 2023 Apr 6;9:20552076231167009. doi: 10.1177/20552076231167009. eCollection 2023 Jan-Dec.

  PMID: 37051564 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 20, 2021
• Study Start: September 27, 2021
• Primary Completion: January 5, 2024
• Study Completion: June 5, 2024
• Last Updated: September 30, 2025

Record last verified: 2023-09

Locations

FR (1)