RecruitingNot ApplicableNCT05988385

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

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

Sponsor

California Pacific Medical Center Research Institute

Enrollment

200 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Cognitive Decline Obstructive Sleep Apnea

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

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether successfully treating moderate-to-severe obstructive sleep apnea (OSA) — a condition where you repeatedly stop breathing during sleep — can improve memory and lower the risk of Alzheimer's disease in older adults. **You may be eligible if...** - You are between 55 and 85 years old - You have normal cognitive function - You have moderate to severe sleep apnea (as confirmed by a sleep study) **You may NOT be eligible if...** - You already have memory problems or cognitive impairment - Your sleep apnea is mild or you have already been successfully treated - You are outside the 55-85 age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPositive airway pressure

Positive 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.

DEVICEOral appliance therapy

Oral 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.

DEVICEPositional therapy

A 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.