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

OSA Clinical Trial

— REMAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435794
• Other study ID #: 2022-A00629-34
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: October 15, 2026

Study information

• Verified date: May 2024
• Source: ResMed
• Contact: Elodie Aversenq
• Phone: +33426100200
• Email: elodie.aversenq[@]resmed.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 15, 2026
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• OSA

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Centre Hospitalier Universitaire Grenoble Alpes	Grenoble
France	CHU Lyon - Hôpital de la Croix-Rousse	Lyon
France	Hopital Europeen Marseille	Marseille
France	AP-HP Bichat	Paris
France	APHP - Pitié-Salpêtrière University Hospital	Paris
France	CHU Reims	Reims
France	Polyclinique St Laurent	Rennes
France	Centre du Sommeil	Saint-Martin-d'Hères

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months