Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: functional magnetic resonance imaging.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea Syndrome. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions
Overview
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.
Interventions
- Diagnostic test functional magnetic resonance imaging
functional magnetic resonance imaging
Primary outcome measures
- Premotor cortex activation in OSAS patients without CPAP [Time frame: Day 0]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Chu Reims — Reims
Identifiers
NCT: NCT05147649 · PA21141*