Phase 1
Completed N=88
Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
Source: ClinicalTrials.gov NCT05094271 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Apnea Hypopnea Index - Crossover — 34.9; 39.6 units on a scale
Summary
Obstructive sleep apnea (OSA) is common in older adults and has recently been implicated in pathogenesis of Alzheimer's disease (AD). Research has shown that sleep disruptions have caused memory impairment. Sleep apnea is a form of sleep disruption. We would like to examine how obstructive sleep apnea may contribute to the progression of Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index - Crossover |
34.9; 39.6 | — |
| PRIMARY Loop Gain (LG) - Crossover |
0.52; 0.60 | — |
| PRIMARY Neuroimaging - BRAAK12 tauPET |
0.91; 0.92 | — |
| SECONDARY Epworth Sleepiness Scale (ESS) - Parallel |
-0.50; 0.14; -0.22; -0.43; 1.00; -1.8 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) - Parallel |
-1.29; -0.71; 0.78; -1.57; -1.50; 0.80 | — |
| SECONDARY Insomnia Severity Index (ISI) - Parallel |
-1.43; -3.14; -0.89; -4.00; -0.50; 0.60 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05094271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.