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

CHU de Reims

Status: Enrolling

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Diagnostic Test: functional magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05147649

PA21141*

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

non-OSAS patients

Active Comparator group

Description:

Patients without OSAS (Apnea-Hypopnea Index (AHI) \< 15/h and absence of excessive daytime sleepiness with Epworth score \<11)

Treatment:

Diagnostic Test: functional magnetic resonance imaging

OSAS patients

Experimental group

Description:

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

Treatment:

Diagnostic Test: functional magnetic resonance imaging