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

• Sponsor: ResMed (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05435794
• Collaborator: (none)
• Enrollment: 400
• Anticipated Duration (Months): 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
OSA	Device: CPAP; Device: MAD

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea
• Anticipated Study Start Date: Jul 15, 2022
• Anticipated Primary Completion Date: Oct 15, 2022
• Anticipated Study Completion Date: Oct 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patient treated with CPAP	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.
Patient treated with MAD	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.

Outcome Measures

Primary Outcome Measures

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). [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34)

• 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

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ResMed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ResMed
• ClinicalTrials.gov Identifier: NCT05435794
• Other Study ID Numbers: 2022-A00629-34
• First Posted: Jun 28, 2022
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 28, 2022