Examining brain activity in patients with obstructive sleep apnea
Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions
This study is testing how the brains of people with obstructive sleep apnea react to breathing challenges while they are awake to see if it affects their thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Trial ID | NCT05147649 on ClinicalTrials.gov |
What this trial studies
This study investigates the brain's cortical activity in patients with obstructive sleep apnea syndrome (OSAS) while they are awake. It aims to determine if these patients exhibit similar respiratory-related cortical responses as normal subjects when subjected to inspiratory loading. Additionally, the study will analyze whether these cortical compensatory mechanisms have any cognitive consequences. The intervention involves the use of functional magnetic resonance imaging (fMRI) to observe brain activity patterns.
Who should consider this trial
Good fit: Ideal candidates include adults with severe obstructive sleep apnea (AHI > 30/h) who are not currently receiving CPAP treatment.
Not a fit: Patients with other sleep disorders, neurological or respiratory pathologies, or those who cannot undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the cognitive impacts of obstructive sleep apnea and lead to improved treatment strategies.
How similar studies have performed: While similar studies have explored brain activity in sleep apnea, this specific approach using fMRI in awake patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Reims
- Chu Reims — Reims, France (Recruiting)
Study contacts
- Study coordinator: Claire Launois
- Email: claunois@chu-reims.fr
- Phone: 3 26 78 83 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.