Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CPAP, MAD.
- Who it may be relevant to
- Registry conditions: OSA. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea
Overview
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.
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.
Primary outcome measures
- 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). [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 9 centers
- CHU Angers — Angers
- Centre Hospitalier Universitaire Grenoble Alpes — Grenoble
- CHU Lyon - Hôpital de la Croix-Rousse — Lyon
- Hopital Europeen Marseille — Marseille
- APHP - Pitié-Salpêtrière University Hospital — Paris
- AP-HP Bichat — Paris
- CHU Reims — Reims
- Polyclinique St Laurent — Rennes
- … and 1 more center
Identifiers
NCT: NCT05435794 · 2022-A00629-34