Investigating long-term effects of CPAP or MAD on sleep in OSA patients
Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea
This study is testing how well CPAP or MAD treatments improve sleep quality over a year for people with obstructive sleep apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | ResMed Industry-sponsored |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT05435794 on ClinicalTrials.gov |
What this trial studies
The REMAP study follows a cohort of 400 patients across approximately ten sleep centers in France to collect clinical data on the management of obstructive sleep apnea (OSA) using CPAP or MAD treatments. It aims to assess the impact of one year of treatment on sleep architecture through objective measurements obtained from a home sleep test device. Additionally, the study will evaluate patient-reported quality of sleep and quality of life, while identifying predictive factors that may enhance sleep quality during OSA treatment.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 to 80 with OSA who are eligible for CPAP or MAD therapy and have undergone a sleep test.
Not a fit: Patients who have been treated for OSA with CPAP or MAD in the last five years or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with OSA, enhancing their sleep quality and overall quality of life.
How similar studies have performed: Other studies have shown success in evaluating the effects of CPAP and MAD on OSA, making this approach both relevant and supported by prior findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34) or Patient who has undergone polygraphy or polysomnography eligible for treatment with CPAP or MAD in the context of OSA. * Patient with a sleep test performed with the Sunrise device * Men or Women from 18 to 80 years old * Patient with OSAS eligible for CPAP or MAD therapy * Affiliated patient or beneficiary of a social security scheme * Signed informed consent Exclusion Criteria: * Patient previously treated for OSAS by CPAP or MAD during the last five years * Patient with COPD or other respiratory diseases. * Patient with contraindications to PPC or MAD therapy * Patient with unstable heart disease or New York Heart Association class III or IV heart failure * Patient unable to complete the study
Where this trial is running
Angers and 8 other locations
- CHU Angers — Angers, France (Recruiting)
- Centre Hospitalier Universitaire Grenoble Alpes — Grenoble, France (Recruiting)
- CHU Lyon - Hôpital de la Croix-Rousse — Lyon, France (Recruiting)
- Hopital Europeen Marseille — Marseille, France (Recruiting)
- APHP - Pitié-Salpêtrière University Hospital — Paris, France (Recruiting)
- AP-HP Bichat — Paris, France (Not_yet_recruiting)
- CHU Reims — Reims, France (Recruiting)
- Polyclinique St Laurent — Rennes, France (Recruiting)
- Centre du Sommeil — Saint-Martin-d'Hères, France (Recruiting)
Study contacts
- Study coordinator: Elodie Aversenq
- Email: elodie.aversenq@resmed.fr
- Phone: +33426100200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.