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

Eligibility Criteria

Sex
ALL
Age
65 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Supplemental Oxygen — OTHER
    Subjects 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 — DEVICE
    Continuous 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 — OTHER
    Subjects 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 PSG
    Subjects 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 PSG
    Subjects 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 Months
    Over 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 Months
    Over 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)

FacilityCityStateZIPSite coordinators
UCSD Sleep ResearchLa JollaCalifornia92037-

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