Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome

NCT05147649 | Recruiting

• 1 other identifier: PA21141*
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• Premotor cortex activation in OSAS patients without CPAP

  Day 0

Study Arms (2)

non-OSAS patients

ACTIVE COMPARATOR

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

OSAS patients

EXPERIMENTAL

Patients with severe OSAS with an Apnea-Hypopnea Index (AHI) \> 30/h

Diagnostic Test: functional magnetic resonance imaging

Interventions

functional magnetic resonance imaging DIAGNOSTIC_TEST

functional magnetic resonance imaging

OSAS patients; non-OSAS patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OSAS patients
• severe OSAS with an Apnea-Hypopnea Index (AHI) \> 30/h
• without CPAP treatment
• Non-OSAS patients
• absence of OSAS (AHI \< 15/h and absence of excessive daytime sleepiness with Epworth score \<11)
• \< 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.),

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Claire Launois

CONTACT

3 26 78 83 70; claunois@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 7, 2021
• Study Start: March 2, 2023
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): July 2, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

FR (1)