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.
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
Not currently on therapy for OSA and has not received treatment for OSA for at least 6months
Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - an answer of severe or very severe in the screening form
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
Parallel
Positive airway pressure
DevicePositive airway pressure (PAP) therapy is a sleep apnea treatment that uses a stream of compressed air to support the airway during sleep. With PAP therapy, a mask is worn during sleep and a portable machine gently blows pressurized room air from into your upper airway through a tube connected to the mask. This positive airflow helps keep the airway open, preventing the collapse that occurs during apnea, thus allowing normal breathing.
Oral appliance therapy
DeviceOral appliance therapy involves the use of a dental appliance or oral mandibular advancement device that prevents the tongue from blocking the throat and/or advances the lower jaw forward. These devices help keep the airway open during sleep.
Positional therapy
DeviceA NightShift Sleep Positioner (Advanced Brain Monitoring) is a neck vibration device, FDA approved to treat positional sleep apnea. The device detects patient supine position and delivers a small vibratory signal to the back of the neck to prompt position change.
Change in overnight memory retention on the A-B verbal paired associates task
Mean change in percent correct memory
Change in overnight memory retention on the A-B verbal paired associates task
Mean change in percent correct memory
Change in overnight memory retention on the A-B verbal paired associates task
Mean change in percent correct memory
Change in Aβ42/ Aβ40 ratio
Mean change in the Aβ42/ Aβ40 ratio in picograms per millimeter (pg/ml)
Change in Task-switching Accuracy
Change in Task-switching Mean Percent Accuracy
Change in Task-switching Accuracy
Change in Task-switching Mean Percent Accuracy
Change in Task-switching Accuracy
Change in Task-switching Mean Percent Accuracy
Change in Task-switching Reaction Time
Change in Task-switching Mean Reaction Time in milliseconds
Cognitive Impairment Severity
Severity of cognitive impairment based on normed cutoffs with the National Alzheimer's Coordinating Centers Uniform Data Set-3 (UDS-3) assessment.
Cognitive Impairment Severity
Severity of cognitive impairment based on normed cutoffs with the National Alzheimer's Coordinating Centers Uniform Data Set-3 (UDS-3) assessment.
Clinical Dementia Rating (CDR) Scale (0-3)
Clinical Dementia Rating on a scale of 0-3 based on clinical assessment, 0 being no impairment, and 3 being severe impairment.
Sleepiness Score
Epworth Sleepiness Scale (ESS) Questionnaire Score. Higher scores mean more severe sleepiness.
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California Pacific Medical Center Research Institute
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborator
New York University
Collaborator
University of Arizona
Collaborator
University of Pittsburgh
Collaborator
National Institute on Aging (NIA)
Collaborator
