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

ID#: NCT05988385

Age: 55 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: April 22, 2024

End Date: May 31, 2028

Contact Information:
Dana R Kriesel, MPH
415-476-6128
Katie L Stone, PhD
415-476-6128
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:

Inclusion Criteria:

- Cognitively normal (TiCS>29

- 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)

- Not currently on therapy for OSA and has not received treatment for OSA for at least 12 months

- Able and willing to be treated for OSA

- Fluency in English or Spanish

Exclusion Criteria:

- Documented diagnosis of chronic insomnia.

- Severe or very severe difficulty falling asleep.

- Documented diagnosis of circadian rhythm disorder.

- Any current use of supplemental oxygen.

- Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria

- Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo

- Chronic regular (> 2 nights per week) use of any sedative, stimulant, neuroleptic drugs, or other medications limiting validity of cognitive tests. This includes regular use of alcohol or cannabis for sleep. Melatonin is ok.

- Diagnosis of uncontrolled psychiatric disease in the last six months , and/or history of schizophrenia or bipolar disorder. Controlled conditions will include major depressive disorder, panic disorder, generalized anxiety disorder, OCD, substance use disorders, and alcohol abuse/dependence. (medical record/EHR). Personality disorders and neurodevelopmental disorders (e.g. autism, ADHD) are allowed if cognition is within normal limits.

- Taking methylphenidate for ADHD.

- Presence of other critical comorbid conditions that would lead to inability to complete the study protocol (including follow-up for 2 years), or that would affect cognition (e.g. clinically relevant endocrine or hematological conditions).

- Does not have a regular sleeping environment (i.e., sleeps in a different setting > 2 nights per week).

- Currently pregnant or planning to become pregnant.

- Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, a loss of consciousness > 24 hours, or traumatic brain injury as identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with MCI or Alzheimer's disease based on neuropsychological testing will be excluded. Delirium in the last 12 months.

- Near-miss or prior automobile accident "due to sleepiness" within the past 12 months.

- Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots).
Find a Clinical Trial Find Cancer Clinical Trials