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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
functional magnetic resonance imaging
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chu ReimsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

non-OSAS patients

OSAS patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Premotor cortex activation in OSAS patients without CPAP

Secondary Outcome Measures

Full Information

First Posted
November 29, 2021
Last Updated
March 6, 2023
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT05147649
Brief Title
Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome
Acronym
IRM SAOS
Official Title
Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
March 2, 2024 (Anticipated)
Study Completion Date
September 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non-OSAS patients
Arm Type
Active Comparator
Arm Description
Patients without OSAS (Apnea-Hypopnea Index (AHI) < 15/h and absence of excessive daytime sleepiness with Epworth score <11)
Arm Title
OSAS patients
Arm Type
Experimental
Arm Description
Patients with severe OSAS with an Apnea-Hypopnea Index (AHI) > 30/h
Intervention Type
Diagnostic Test
Intervention Name(s)
functional magnetic resonance imaging
Intervention Description
functional magnetic resonance imaging
Primary Outcome Measure Information:
Title
Premotor cortex activation in OSAS patients without CPAP
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Launois
Phone
3 26 78 83 70
Ext
0033
Email
claunois@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome

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