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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
California Pacific Medical Center Research Institute
Study ID
NCT05988385
Status
Recruiting
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Conditions

  • Cognitive Decline
  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Positive airway pressure — DEVICE
    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.
  • Oral appliance therapy — DEVICE
    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.
  • Positional therapy — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 22, 2024
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 3-month OSA treatment
    A 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI3a\<15 (rapid multi-modal treatment RMMT).
  • Other: Waitlist control group
    A waitlist control group to receive treatment at the conclusion of the 3-month intervention period.

Primary Outcome Measure

Change in overnight memory retention on the A-B verbal paired associates task [ Time Frame: 3 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85719
Sairam Parsasarathy, MD (PRINCIPAL_INVESTIGATOR)
Mount SinaiNew YorkNew York10023
Andrew Varga, MD (PRINCIPAL_INVESTIGATOR)
Jay Guevarra, MD (PRINCIPAL_INVESTIGATOR)
New York UniversityNew YorkNew York10016
Acibiades Rodriguez, MD (PRINCIPAL_INVESTIGATOR)
Ricardo Osorio, MD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15213
Sanjay Patel, MD (PRINCIPAL_INVESTIGATOR)

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