Actively Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Led by California Pacific Medical Center Research Institute · Updated on 2025-11-10
200
Participants Needed
4
Research Sites
214 weeks
Total Duration
On this page
Sponsors
C
California Pacific Medical Center Research Institute
Lead Sponsor
I
Icahn School of Medicine at Mount Sinai
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cognitively normal (TiCS 629)
- Age between 55 and 85 years
- Diagnosed with moderate to severe obstructive sleep apnea (AHI4 620 events/hour or AHI3A >40/hour) confirmed within the past 12 months
- Not currently being treated for obstructive sleep apnea and no treatment received in the past 6 months
- Able and willing to undergo treatment for obstructive sleep apnea
- Fluent in English or Spanish
You will not qualify if you...
- Diagnosed with chronic insomnia or severe sleep onset insomnia
- Diagnosed with circadian rhythm disorder
- Currently using supplemental oxygen
- Having other sleep-related breathing disorders such as central sleep apnea
- Working night shifts regularly within the past 6 months
- Scheduled for bariatric surgery within the next 3 months
- Regular cannabis use for sleep more than 2 nights per week
- Uncontrolled psychiatric disease in the last 6 months or history of schizophrenia or bipolar disorder
- Taking methylphenidate for ADHD unless on stable dose reviewed by investigator
- Using GLP-1 agonists or similar medications for weight loss with plans to lose 20 pounds or more
- Having serious comorbid conditions affecting cognition or ability to complete the study
- Not having a regular sleeping environment (sleeping in different settings more than 2 nights per week)
- Currently pregnant or planning pregnancy
- Prior diagnosis of central nervous system diseases such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, long loss of consciousness, or traumatic brain injury
- Diagnosed with mild cognitive impairment or Alzheimer's disease
- Experienced delirium in the past 12 months
- Had a near-miss or accident related to sleepiness in the past 12 months
- Employed as a commercial driver during the study
- Using neuroleptics, benzodiazepines, barbiturates, opiates, or anti-amyloid therapies
- Recently started or not stable on cognitive enhancing drugs
- Consuming more than 14 alcoholic drinks per week unless consumption can be reduced
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Arizona
Tucson, Arizona, United States, 85719
Actively Recruiting
2
New York University
New York, New York, United States, 10016
Actively Recruiting
3
Mount Sinai
New York, New York, United States, 10023
Actively Recruiting
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
L
Lisa Takemori
CONTACT
K
Katie L Stone, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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