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

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.

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Key information

Conditions

OSA

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

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.

MAD

Device

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 outcomes

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie Aversenq

CONTACT

[email protected]

+33426100200

Florent Lavergne

CONTACT

[email protected]

+33426100200

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea

Acronym: REMAP

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2026
First posted: Jun 28, 2022
Registry last updated: May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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