Obstructive Sleep Apnea SyndromeIRM SAOSNCT05147649
Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome
A study testing functional magnetic resonance imaging in people with Obstructive Sleep Apnea Syndrome, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- functional magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2023to 2 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 18Show fewer
- < 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions
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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- functional magnetic resonance imaging
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional magnetic resonance imagingDiagnostic test
functional magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| non-OSAS patients | Active comparator | Patients without OSAS (Apnea-Hypopnea Index (AHI) < 15/h and absence of excessive daytime sleepiness with Epworth score <11) Receives: Diagnostic Test: functional magnetic resonance imaging |
| OSAS patients | Experimental | Patients with severe OSAS with an Apnea-Hypopnea Index (AHI) > 30/h Receives: Diagnostic Test: functional magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premotor cortex activation in OSAS patients without CPAP
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start2 Mar 2023
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147649
- Sponsor's protocol ID
- PA21141*
- Acronym
- IRM SAOS
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2021
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions
- ClinicalTrials.gov ID
- NCT05147649
- Acronym / sponsor ID
- IRM SAOS / PA21141*
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jul 2027 (estimated)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-OSAS patients | Active comparator | Diagnostic Test: functional magnetic resonance imagingPatients without OSAS (Apnea-Hypopnea Index (AHI) < 15/h and absence of excessive daytime sleepiness with Epworth score <11) |
| OSAS patients | Experimental | Diagnostic Test: functional magnetic resonance imagingPatients with severe OSAS with an Apnea-Hypopnea Index (AHI) > 30/h |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- OSAS patients
- Non-OSAS patients
- < 18 years old
- >75 years old
- left-handed
Key exclusion criteria (7 listed)
- pregnant woman according to the positive beta-hCG test result
- left-handed following the laterality questionnaire
- MINI results showing:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional magnetic resonance imagingfunctional magnetic resonance imaging | Diagnostic test | OSAS patients, non-OSAS patients |
Primary outcome
Premotor cortex activation in OSAS patients without CPAP
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional magnetic resonance imaging in people with Obstructive Sleep Apnea Syndrome, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Launois (3 26 78 83 70 ext. 0033, claunois@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premotor cortex activation in OSAS patients without CPAP (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.