Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
ConditionOSA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorResMed
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients will be recruited based on scheduled appointments at the various centers that participate in the SunSAS clinical trial and are diagnosed and managed for their OSA in accordance with standard practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CPAP
DeviceFixed-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.
MAD
Devicemandibular 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Patient treated with CPAP1 intervention
Group B: Patient treated with MAD1 intervention
Trial outcomes
Primary outcomes
1
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).
Objective evolution of deep slow-wave sleep time. Changes collected with a home-connected sleep testing device by comparing data from the initial visit (diagnosis) with data collected at 12 months (± 2 weeks) in a patient treated with CPAP or MAD.
Time frame
12 months Source ClinicalTrials.gov