Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome (IRM SAOS)

November 28, 2025 updated by: CHU de Reims

Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions

The obstructive sleep apnea syndrome (OSAS) involves recurrent sleep-related upper airways (UA) collapse. UA mechanical properties and neural control are altered, imposing a mechanical load on inspiration. UA collapse does not occur during wakefulness, hence arousal-dependent compensation. Experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. The objective of this study is to test whether awake OSAS patients would exhibit a similar cortical activity. Whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Reims, France, 51092
        • Recruiting
        • Chu Reims
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria :

  1. OSAS patients

    • severe OSAS with an Apnea-Hypopnea Index (AHI) > 30/h
    • without CPAP treatment

  2. Non-OSAS patients

    • absence of OSAS (AHI < 15/h and absence of excessive daytime sleepiness with Epworth score <11)

Non-inclusion criteria :

  • < 18 years old
  • >75 years old
  • left-handed
  • BMI> 40 kg/m²
  • another sleep disorder
  • central component of sleep apnea syndrome (central apnea index> 5 / h)
  • current or past neurological pathology
  • respiratory pathology (obstructive ventilatory disorder, restrictive ventilatory disorder, hypercapnia)
  • MRI contraindication (metallic foreign body, claustrophobia, pregnant woman, etc.)
  • taking drugs that can modify the BOLD signal on MRI (psychotropic drugs, vasodilators, vasoconstrictors, etc.),
  • uncorrected sensory impairment (vision or hearing)
  • protected by law.

Exclusion criteria :

  • pregnant woman according to the positive beta-hCG test result
  • left-handed following the laterality questionnaire

  • MINI results showing:

    • a current mood episode
    • a current disorder of the use of psychoactive substances or in the last 6 months (excluding tobacco)
    • an eating disorder
    • a diagnosis of bipolar disorder, current or past schizophrenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: non-OSAS patients
Patients without OSAS (Apnea-Hypopnea Index (AHI) < 15/h and absence of excessive daytime sleepiness with Epworth score <11)
Diagnostic test: functional magnetic resonance imaging
functional magnetic resonance imaging
Experimental: OSAS patients
Patients with severe OSAS with an Apnea-Hypopnea Index (AHI) > 30/h
Diagnostic test: functional magnetic resonance imaging
functional magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Premotor cortex activation in OSAS patients without CPAP
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Estimated)

January 2, 2027

Study Completion (Estimated)

July 2, 2027

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA21141*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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