Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
REMAP
Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea
1 other identifier
observational
400
1 country
9
Brief Summary
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2026
ExpectedMay 21, 2024
May 1, 2024
3 months
June 14, 2022
May 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the evolution of deep slow-wave sleep at one year in OSA patients according to the treatment initiated by continuous positive pressure or mandibular advancement device (MAD).
Objective evolution of deep slow-wave sleep time. Changes collected with a home-connected sleep testing device by comparing data from the initial visit (diagnosis) with data collected at 12 months (± 2 weeks) in a patient treated with CPAP or MAD.
12 months
Study Arms (2)
Patient treated with CPAP
Patient treated with MAD
Interventions
Fixed-pressure CPAP device for the treatment of sleep apnea with optional humidification and heated circuit. This device is a Class II device. It has a remote monitoring function allowing service providers to track the use of the device.
mandibular device orthosis made to measure from the dental impressions of patients, made by the specialist in the masticatory apparatus for the treatment of sleep apnea.
Eligibility Criteria
Patients will be recruited based on scheduled appointments at the various centers that participate in the SunSAS clinical trial and are diagnosed and managed for their OSA in accordance with standard practice.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (9)
CHU Angers
Angers, 49933, France
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043, France
CHU Lyon - Hôpital de la Croix-Rousse
Lyon, 69004, France
Hopital Europeen Marseille
Marseille, 13003, France
APHP - Pitié-Salpêtrière University Hospital
Paris, 75013, France
AP-HP Bichat
Paris, 75018, France
CHU Reims
Reims, 51092, France
Polyclinique St Laurent
Rennes, France
Centre du Sommeil
Saint-Martin-d'Hères, 38400, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2022
First Posted
June 28, 2022
Study Start
July 15, 2022
Primary Completion
October 15, 2022
Study Completion (Estimated)
October 15, 2026
Last Updated
May 21, 2024
Record last verified: 2024-05