Impact of Continuous Positive Airway Pressure Therapy on Bilateral Local Hippocampal Gray Matter Volume in Elderly Patients With Obstructive Sleep Apnea - Study BBBSAS
Key facts
- Who runs it
- Centre Hospitalier Universitaire de Saint Etienne
- Where
- Saint-Etienne, FranceSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 50 people, planned
- Started
- 1 Nov 2026
- Expected to end
- 1 Nov 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Continuous Positive Airway Pressure (CPAP) therapy
- Multimodal brain MRI with Gadolinium injection
- Record updated
- 20 October 2026
Who can take part
- Age
- 70 years and older
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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 take part
- Contraindication to Gadolinium injection (prior allergic reaction to a contrast agent)
- Contraindication to MRI (pacemaker, metallic heart valve, ocular metallic foreign body…)
- Type 1 or type 2 diabetes
- History of stroke or congestive heart failure
- Severe chronic renal insufficiency
- Chronic respiratory insufficiency requiring oxygen therapy
- Sleep-related neurological disorder or chronic insomnia
- Known neurodegenerative disease
- Daily use of hypnotics, anxiolytics, antidepressants, antipsychotics, or antiepileptics
- Central sleep apnea (central AHI > 15 or more than 5% central events)
- Participation in another study that could affect cognitive function or sleepiness
Where in France
- CHU Saint-EtienneSaint-Etienne, FranceContact: Fédéric PHD ROCHENo longer taking part
About the trial
What the trial wants to find out
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).
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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.
The 2 groups in the trial
- SHAOS groupTreatment being tested
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.
Treatment: Continuous Positive Airway Pressure (CPAP) therapy
- Control GroupOther group
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).
Treatment: Multimodal brain MRI with Gadolinium injection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 20 October 2026