Hypopnea SyndromeBBBSASNCT07882433
Impact of Continuous Positive Airway Pressure Therapy on Bilateral Local Hippocampal Gray Matter Volume in Elderly Patients With Obstructive Sleep Apnea - Study BBBSAS
A study testing Continuous Positive Airway Pressure (CPAP) therapy and Multimodal brain MRI with Gadolinium injection in people with Hypopnea Syndrome and Apnea, Obstructive Sleep, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
This study evaluates whether treating severe obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) for approximately 6 months modifies local hippocampal and frontal cortex gray matter volume and blood-brain barrier (BBB) permeability in elderly men. Read more about this study
- Who is it for?
- Ages 70 years and older, men only
- Conditions the study is for
- Hypopnea Syndrome, Apnea, Obstructive Sleep
- What is being tested?
- Continuous Positive Airway Pressure (CPAP) therapy and Multimodal brain MRI with Gadolinium injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Interventional
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 70 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Affiliated with or entitled to French social security coverage
- Informed and signed consent to participate
- Newly diagnosed, previously untreated severe obstructive sleep apnea (AHI > 30)
- Male sex
- Aged 70 years or older, no upper age limit
- Native French speaker, able to complete all study procedures
Who cannot join
- Contraindication to MRI (pacemaker, metallic heart valve, ocular metallic foreign body…)
- Contraindication to Gadolinium injection (prior allergic reaction to a contrast agent)
- Type 1 or type 2 diabetes
- History of stroke or congestive heart failure
- Severe chronic renal insufficiency
- Chronic respiratory insufficiency requiring oxygen therapy
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- Daily use of hypnotics, anxiolytics, antidepressants, antipsychotics, or antiepileptics
- Sleep-related neurological disorder or chronic insomnia
- Known neurodegenerative disease
- Central sleep apnea (central AHI > 15 or more than 5% central events)
- Participation in another study that could affect cognitive function or sleepiness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study evaluates whether treating severe obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) for approximately 6 months modifies local hippocampal and frontal cortex gray matter volume and blood-brain barrier (BBB) permeability in elderly men. Twenty-five men aged 70 years or older with newly diagnosed, previously untreated severe OSA (apnea-hypopnea index [AHI] > 30) are compared with 25 age- and body-mass-index-matched control men without OSA (AHI < 10, oxygen desaturation index < 10).
All participants undergo a comprehensive neurocognitive assessment, instrumented gait and balance analysis, blood and urine sampling for systemic inflammatory and aquaporin markers, and a multimodal brain MRI with intravenous Gadolinium injection to quantify BBB permeability and gray/white matter volume. Patients repeat the MRI, cognitive testing, and gait/balance assessment after approximately 6 months of CPAP therapy, once adequate treatment adherence (≥5 hours/night).
The main hypothesis is that severe untreated OSA is associated with focal BBB permeability abnormalities in the hippocampus and frontal cortex, and that effective CPAP treatment partially reverses these anatomical and functional changes, together with improvements in executive/memory performance, gait, balance, and systemic inflammation. Results are expected to clarify the neurocognitive impact of OSA in the elderly, help target patients who most need treatment, and identify complementary pharmacological targets.
- Conditions
- Hypopnea Syndrome, Apnea, Obstructive Sleep
- Being tested
- Continuous Positive Airway Pressure (CPAP) therapy, Multimodal brain MRI with Gadolinium injection
- Keywords
- sleep apnea, CPAP, hippocampus, gray matter volume, blood-brain barrier, MRI, elderly, aging, cognition, aquaporin
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP) therapyDevice
Standard-of-care nocturnal CPAP ventilation, initiated per usual clinical practice in patients diagnosed with severe OSA and continued for approximately 6 months. Treatment tolerance, efficacy, and average adherence (target ≥5 hours/night) are checked at a clinical visit after 4 months of treatment.
Multimodal brain MRI with Gadolinium injectionDevice
One-hour, 6-sequence brain MRI protocol (3D T1 MP2RAGE, T2 relaxometry, 60-direction diffusion tensor imaging, T2* susceptibility-weighted imaging, dynamic contrast-enhanced perfusion imaging, and post-Gadolinium 3D T1 MPRAGE), used to quantify blood-brain barrier permeability (permeability-surface area product) and local gray/white matter volume by voxel-based morphometry and automated hippocampal segmentation. Gadobutrol (Gadovist®) 0.1 mmol/kg is injected intravenously during the 5th sequence via a venous catheter placed before the first sequence. Performed once in control subjects and twice in patients (before and after approximately 6 months of CPAP).
| Study group | Role | What they receive |
|---|---|---|
| SHAOS group | Experimental | Description: Men aged 70 years or older with severe, previously untreated obstructive sleep apnea (AHI > 30) confirmed by polysomnography. Participants receive standard nocturnal CPAP therapy for approximately 6 months, per usual clinical practice. Receives: Device: Continuous Positive Airway Pressure (CPAP) therapy |
| Control Group | Other | Description: Men aged 70 years or older without obstructive sleep apnea (AHI < 10, oxygen desaturation index < 10) confirmed by ambulatory polysomnography, matched to patients for age (±3 years) and BMI (±3). No CPAP intervention; single assessment visit (MRI, cognitive testing, gait/balance analysis, blood and urine sampling). Receives: Device: Multimodal brain MRI with Gadolinium injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-brain barrier (BBB) permeability abnormality in the hippocampus and frontal cortex
Assessed using a multimodal MRI protocol (3D T1 MP2RAGE, T2 relaxometry, diffusion tensor imaging, T2* susceptibility-weighted imaging, dynamic contrast-enhanced perfusion imaging providing the permeability-surface area product [PS], and post-Gadolinium 3D T1 MPRAGE), analyzed by voxel-based morphometry and automated hippocampal segmentation.
Measured: months 6
Secondary outcomes (5)
Blood-brain barrier (BBB) permeability abnormality in the hippocampus and frontal cortex
Assessed using a multimodal MRI protocol (3D T1 MP2RAGE, T2 relaxometry, diffusion tensor imaging, T2* susceptibility-weighted imaging, dynamic contrast-enhanced perfusion imaging providing the permeability-surface area product [PS], and post-Gadolinium 3D T1 MPRAGE), analyzed by voxel-based morphometry and automated hippocampal segmentation.
Measured: months : 6
Local white matter volume
Voxel-level gray-scale analysis of white matter, using the same MRI acquisitions and analysis pipeline as the primary outcome.
Measured: 6 months
Dysexecutive / memory cognitive score
Composite score derived from a neuropsychological battery (Stroop test, Trail Making Test A/B, verbal fluency, digit span, WAIS-III subtests, free/cued recall, PASAT).
Measured: 6 months
Dual-task gait and balance performance
Step variability and balance time under single- and dual-task walking conditions, measured with pressure-sensor insoles and a force platform.
Measured: 6 months
Systemic inflammatory and aquaporin biomarkers
Serum hs-CRP, IL-1β, IL-6, IL-10, TNF-α and MCP-1 (Luminex®); serum and urinary aquaporin 1 and 3 (ELISA).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopnea SyndromeStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882433
- Sponsor's protocol ID
- 19CH044
- Other IDs
- ANSM
- Acronym
- BBBSAS
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No