The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults (ESSENTIAL) Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an effective AHI4%\< 10/hour and AHI3A\<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:

• Cognitively normal (TiCS ≥29)

• Age 55-85 years

• Moderate - severe OSA defined as AHI4 ≥20 events/hour or AHI3A\>40/hr using a hypopnea criterion of a 4% oxygen desaturation (AHI4) or 3% oxygen desaturation and/or EEG arousal (AHI3A), or equivalent based on in-home testing - Testing must have been completed in past 12 months or confirmed by repeat test (EHR)

• Not currently on therapy for OSA and has not received treatment for OSA for at least 6months

• Able and willing to be treated for OSA (Treatment group)

• Fluency in English or Spanish

Locations
United States
Arizona
University of Arizona
RECRUITING
Tucson
New York
Mount Sinai
RECRUITING
New York
New York University
RECRUITING
New York
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Lisa Takemori
lisa.takemori@ucsf.edu
415-633-6229
Backup
Katie L Stone, PhD
katie.stone@ucsf.edu
415-476-6128
Time Frame
Start Date: 2024-04-22
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 200
Treatments
Active_comparator: 3-month OSA treatment
A 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an effective AHI3a\<15 (rapid multi-modal treatment RMMT).
Other: Waitlist control group
A waitlist control group to receive treatment at the conclusion of the 3-month intervention period.
Related Therapeutic Areas
Sponsors
Collaborators: University of Arizona, Icahn School of Medicine at Mount Sinai, University of Pittsburgh, National Institute on Aging (NIA), New York University
Leads: California Pacific Medical Center Research Institute

This content was sourced from clinicaltrials.gov