Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 85
Healthy Volunteers: f
View:
• 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)
Locations
United States
California
UCSD Sleep Research
RECRUITING
La Jolla
Contact Information
Primary
Pam DeYoung
sleepresearch@health.ucsd.edu
8582462154
Backup
Pamela DeYoung
pdeyoung@health.ucsd.edu
8582462154
Time Frame
Start Date: 2021-06-30
Estimated Completion Date: 2025-05-20
Participants
Target number of participants: 260
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego