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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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