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

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.

Conditions

• Obstructive Sleep Apnea
• Cognitive Decline

Interventions

DEVICE

Positive 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.

DEVICE

Oral 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.

DEVICE

Positional 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• New York University

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• California Pacific Medical Center Research Institute

  lead OTHER

Principal Investigators

• Katie L Stone, PhD · California Pacific Medical Center Research Institute

• Ricardo Osorio, MD · New York University

• Andrew Varga, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-22

Primary Completion

2027-06-30

Completion

2028-05-31

FDA Device

Yes

Countries

• United States

Study Locations