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NCT05988385 · ClinicalTrials.gov registry record · NA
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
A NA study of Obstructive Sleep Apnea and Cognitive Decline, sponsored by California Pacific Medical Center Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 4
- Study locations
NCT05988385 is a NA study of Obstructive Sleep Apnea and Cognitive Decline that is actively recruiting participants, run by California Pacific Medical Center Research Institute. The registered enrollment target is 200 participants, roughly in line with the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target. The trial reports 4 study locations across 3 states.
The verdict
NCT05988385, a NA study of Obstructive Sleep Apnea and Cognitive Decline, is actively recruiting participants, sponsored by California Pacific Medical Center Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 4
- Study locations
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 Studied
Interventions
- DEVICE Positive airway pressure
- DEVICE Oral appliance therapy
- DEVICE Positional therapy
Study Locations (4)
New York
- New York University - New York
- Mount Sinai - New York
Arizona
- University of Arizona - Tucson
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-04-22 |
| Est. Completion | 2028-05-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05988385
The ClinicalTrials.gov registry entry for NCT05988385 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target. The listed sponsor is California Pacific Medical Center Research Institute, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 3 interventions - of which Positive airway pressure is the first listed.
NCT05988385 reports 4 study locations spanning 3 distinct geographic areas - top geographies include New York, Arizona, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05988385 about?
NCT05988385 is a clinical study titled "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 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 diag...
What is the current status of trial NCT05988385?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-04-22. Estimated completion is 2028-05-31.
What conditions does trial NCT05988385 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Cognitive Decline.
What interventions are being tested in trial NCT05988385?
The interventions under investigation include: Positive airway pressure (DEVICE), Oral appliance therapy (DEVICE), Positional therapy (DEVICE).
Who is sponsoring clinical trial NCT05988385?
This trial is sponsored by California Pacific Medical Center Research Institute, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05988385 being conducted?
This trial has 4 study locations across Arizona, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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