Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome

NCT ID: NCT05147649

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-02

Study Completion Date

2027-07-02

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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non-OSAS patients

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

Group Type ACTIVE_COMPARATOR

functional magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

functional magnetic resonance imaging

OSAS patients

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

Group Type EXPERIMENTAL

functional magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

functional magnetic resonance imaging

Interventions

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functional magnetic resonance imaging

functional magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)


* \< 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Reims

Reims, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire Launois

Role: CONTACT

3 26 78 83 70 ext. 0033

Facility Contacts

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Damien JOLLY

Role: primary

326788472 ext. 33

Other Identifiers

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PA21141*

Identifier Type: -

Identifier Source: org_study_id

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