RecruitingNCT05435794

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


Sponsor

ResMed

Enrollment

400 participants

Start Date

Jul 15, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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

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Interventions

DEVICECPAP

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.

DEVICEMAD

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

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NCT05435794


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