RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-22
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05988385

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cognitively normal (TiCS\>29
  2. * 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)
  3. * Not currently on therapy for OSA and has not received treatment for OSA for at least 12 months
  4. * Able and willing to be treated for OSA
  5. * Fluency in English or Spanish
  1. * Documented diagnosis of chronic insomnia.
  2. * Severe or very severe difficulty falling asleep.
  3. * Documented diagnosis of circadian rhythm disorder.
  4. * Any current use of supplemental oxygen.
  5. * Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria
  6. * Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo
  7. * 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.
  8. * 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.
  9. * Taking methylphenidate for ADHD.
  10. * 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.
  11. * Does not have a regular sleeping environment (i.e., sleeps in a different setting \> 2 nights per week).
  12. * Currently pregnant or planning to become pregnant.
  13. * 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.
  14. * Near-miss or prior automobile accident "due to sleepiness" within the past 12 months.
  15. * Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots).

Contacts and Locations

Study Contact

Lisa Takemori
CONTACT
415-633-6229
lisa.takemori@ucsf.edu
Katie L Stone, PhD
CONTACT
415-476-6128
katie.stone@ucsf.edu

Principal Investigator

Katie L Stone, PhD
PRINCIPAL_INVESTIGATOR
California Pacific Medical Center Research Institute
Ricardo Osorio, MD
PRINCIPAL_INVESTIGATOR
New York University
Andrew Varga, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85719
United States
New York University
New York, New York, 10016
United States
Mount Sinai
New York, New York, 10023
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: California Pacific Medical Center Research Institute

  • Katie L Stone, PhD, PRINCIPAL_INVESTIGATOR, California Pacific Medical Center Research Institute
  • Ricardo Osorio, MD, PRINCIPAL_INVESTIGATOR, New York University
  • Andrew Varga, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-22
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2024-04-22
Study Completion Date2028-05-31

Terms related to this study

Keywords Provided by Researchers

  • Obstructive Sleep Apnea
  • OSA
  • Cognitive decline
  • Alzheimer Disease
  • AD
  • AD biomarkers
  • Positive Airway Pressure
  • PAP
  • CPAP
  • Oral appliance therapy
  • OAT
  • Positional therapy
  • Sleep-dependent memory

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea
  • Cognitive Decline