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NCT Number: NCT05147649

Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Reims

Reims, 51092, France

Location status: Recruiting

Location contact

Damien JOLLY

CONTACT

[email protected]

326788472 ext. 33

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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

Treatment and study plan

functional magnetic resonance imaging

Diagnostic Test

functional magnetic resonance imaging

Primary outcomes

  1. Premotor cortex activation in OSAS patients without CPAP

    Time frame: Day 0

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Launois

CONTACT

[email protected]

3 26 78 83 70 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: IRM SAOS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 7, 2021
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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