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

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.

Study Overview

• Status: Recruiting
• Conditions: OSA
• Intervention / Treatment: Device: CPAP; Device: MAD

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Elodie Aversenq; Phone Number: +33426100200; Email: elodie.aversenq@resmed.fr
• Study Contact Backup: Name: Florent Lavergne; Phone Number: +33426100200; Email: florent.lavergne@resmed.fr

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • CHU Angers
    • Principal Investigator: Frédéric GAGNADOUX, Prof.
  • Grenoble, France, 38043
    • Recruiting
    • Centre Hospitalier Universitaire Grenoble Alpes
    • Principal Investigator: Jean Louis PEPIN, Pr
  • Lyon, France, 69004
    • Recruiting
    • CHU Lyon - Hôpital de la Croix-Rousse
    • Principal Investigator: Laure Peter-Derex, Dr
  • Marseille, France, 13003
    • Recruiting
    • Hopital Europeen Marseille
    • Principal Investigator: Hervé PEGLIASCO, Pr
  • Paris, France, 75013
    • Recruiting
    • APHP - Pitié-Salpêtrière University Hospital
    • Principal Investigator: Maxime PATOUT, Dr
  • Paris, France, 75018
    • Not yet recruiting
    • AP-HP Bichat
    • Principal Investigator: Marie-Pia D'Ortho, Pr
  • Reims, France, 51092
    • Recruiting
    • Chu Reims
    • Principal Investigator: Claire Launois, Dr
  • Rennes, France
    • Recruiting
    • Polyclinique St Laurent
    • Principal Investigator: Arnaud PRIGENT, Dr
  • Saint-Martin-d'Hères, France, 38400
    • Recruiting
    • Centre du Sommeil
    • Principal Investigator: Renaud Tamisier, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient treated with CPAP	Device: CPAP; 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.
Patient treated with MAD	Device: MAD; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ResMed

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): October 15, 2022
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A00629-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No