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RECRUITING
NCT05435794

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

Sponsor: ResMed

View on ClinicalTrials.gov

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.

Official title: Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2022-07-15

Completion Date

2026-10-15

Last Updated

2024-05-21

Healthy Volunteers

No

Conditions

Interventions

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.

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.

Locations (9)

CHU Angers

Angers, France

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, France

CHU Lyon - Hôpital de la Croix-Rousse

Lyon, France

Hopital Europeen Marseille

Marseille, France

APHP - Pitié-Salpêtrière University Hospital

Paris, France

AP-HP Bichat

Paris, France

CHU Reims

Reims, France

Polyclinique St Laurent

Rennes, France

Centre du Sommeil

Saint-Martin-d'Hères, France