Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients

Recruiting

• Conditions: OSA
• Interventions: Device: MAD; Device: CPAP

• Registration Number: NCT05435794
• Lead Sponsor: ResMed

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-28
• Study Start: 2022-07-15
• Primary Completion: 2022-10-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-21
• Study Completion: 2026-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient treated with MAD	MAD	-
Patient treated with CPAP	CPAP	-

Primary Outcome Measures

Name	Time	Method
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).	12 months	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.

Trial Locations

Locations (9)

Polyclinique St Laurent; 🇫🇷 Rennes, France

CHU Angers; 🇫🇷 Angers, France

Centre Hospitalier Universitaire Grenoble Alpes; 🇫🇷 Grenoble, France

CHU Reims; 🇫🇷 Reims, France

Hopital Europeen Marseille; 🇫🇷 Marseille, France

AP-HP Bichat; 🇫🇷 Paris, France

CHU Lyon - Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France

APHP - Pitié-Salpêtrière University Hospital; 🇫🇷 Paris, France

Centre du Sommeil; 🇫🇷 Saint-Martin-d'Hères, France