An interventional study of Continuous Positive Airway Pressure (CPAP) therapy and Multimodal brain MRI with Gadolinium injection in Hypopnea Syndrome and Apnea, Obstructive Sleep, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Not yet recruiting at 1 site in France. Open to male participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Basic science
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.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's planned enrollment of 50 is close to the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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Exclusion criteria
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.
Device: Continuous Positive Airway Pressure (CPAP) therapy
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).
Device: Multimodal brain MRI with Gadolinium injection
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.
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).
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.
Time frame: months 6
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 6 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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