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

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ResMed

Status

Enrolling

Conditions

OSA

Treatments

Device: CPAP
Device: MAD

Study type

Observational

Funder types

Industry

Identifiers

NCT05435794
2022-A00629-34

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Patient treated with CPAP
Treatment:
Device: CPAP
Patient treated with MAD
Treatment:
Device: MAD

Trial contacts and locations

9

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Central trial contact

Elodie Aversenq; Florent Lavergne

Data sourced from clinicaltrials.gov

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