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NCT05147649 Clinical Trial

Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome

Obstructive Sleep Apnea Syndrome Clinical Trial

— IRM SAOS  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05147649
Other study ID # PA21141*
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2, 2023
Est. completion date July 2, 2026

Study information
Verified date January 2024
Source CHU de Reims
Contact Claire Launois
Phone 3 26 78 83 70
Email claunois@chu-reims.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date July 2, 2026
Est. primary completion date January 2, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• functional magnetic resonance imaging
functional magnetic resonance imaging

Locations
Country Name City State
France Chu Reims Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Premotor cortex activation in OSAS patients without CPAP Day 0
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