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

NCT05435794 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-05-21

No results posted yet for this study

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.

Conditions

  • OSA

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.

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2022-10-15
Completion
2026-10-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435794 on ClinicalTrials.gov