Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
Part of paid clinical trials in La Jolla, California.
- Sponsor
- University of California, San Diego
- Study ID
- NCT05094271
- Phase
- PHASE1
- Status
- Completed
Conditions
- Alzheimer Disease
- OSA
- Obstructive Sleep Apnea
- Sleep Apnea
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Supplemental Oxygen — OTHERSubjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
- Continuous Positive Airway Pressure Machine — DEVICEContinuous positive airway pressure is a form of positive airway pressure ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of a person.
- Room Air — OTHERSubjects will be instrumented with a nasal cannula to receive 2L/min pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
Study Details
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.
Key Dates
- Start date
- Oct 8, 2021
- Status verified
- Mar 2026
- Primary completion
- Jun 12, 2025
- Completion
- Jun 12, 2025
Study Design
- Enrollment
- 182 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Supplemental Oxygen during PSGSubjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
- Placebo Comparator: Room Air during PSGSubjects will be instrumented with a nasal cannula to receive 2L/min of pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats \>90% based on oximetry readings.
- Experimental: Supplemental Oxygen for 3 MonthsOver a 12-week period, participants randomized to receive supplemental Oxygen for treatment of OSA will be contacted weekly to be asked about their adherence. Participants' adherence will also be monitored remotely through cloud-based monitoring.
- Experimental: PAP Therapy for 3 MonthsOver a 12-week period, participants randomized to receive supplemental PAP therapy for treatment of OSA will be contacted weekly to be asked about their adherence. Participants' adherence will also be monitored remotely through cloud-based monitoring.
Primary Outcome Measure
Apnea Hypopnea Index - Crossover [ Time Frame: Over 8 hours on each of the two crossover treatment nights ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSD Sleep Research | La Jolla | California | 92037 | - |
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