NCT05094271 · Phase 1 · RECRUITING
Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
This trial is examining whether obstructive sleep apnea (OSA) contributes to the brain changes associated with Alzheimer's disease. Researchers are comparing supplemental oxygen, CPAP therapy, and room air to see how each affects participants during sleep and what that means for brain health. It is a Phase 1 trial, meaning this is early-stage work focused on safety and feasibility, not a proven treatment approach.
Inclusion criteria
- Age 65-85 years
- Gender: Men or Women
- MOCA > 26
- Independently living and able to drive
- OSA (AHI ≥ 15/h) or no OSA
- Subjects must consent to waiving their right to obtain their PHS score (since the score is not yet actionable and could lead to social stress and ethical dilemmas)
Exclusion criteria
- Currently smoking
- History of COPD or asthma
- Heart Failure Class III or IV, unstable cardiovascular disease, or uncontrolled hypertension
- Neuromuscular Disease
- Drowsy Driving (ESS > 18/24)
- Inability to complete study procedures, such as questionnaire that are only available/validated in English
- Lack of decisional capacity to provide informed consent
- Participants in whom magnetic resonance imaging Magnetic Resonance Imaging [MRI] is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant
- Presence of a brain tumor or lobar stroke
- Current drug or alcohol abuse/dependence
- Prisoners
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-12-27