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*
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

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