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NCT05951023 · ClinicalTrials.gov registry record · Phase 2

Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP)

A Phase 2 study, sponsored by University of California, San Diego.

Completed
Registry status
Phase 2
Development phase
42
Enrollment target

NCT05951023 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 42 participants.

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The verdict

NCT05951023, a Phase 2 study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
Phase 2
Development phase
42 participants
Enrollment target

Study Summary

More than 10% of the US population have obstructive sleep apnea (OSA). Standard of care is therapy with CPAP (continuous positive airway pressure) which virtually eliminates OSA. However, most patients use CPAP only for part of the night (4-5hours) and about 50% patients discontinue CPAP long-term. Alternative therapies are limited, thus many OSA patients remain at risk of OSA sequelae (e.g. sleepiness, memory issues, high blood pressure, etc.). Importantly, different patients get OSA for different reasons, and recent data show that some of the underlying causes of OSA ("endotypes") such as having a low arousal threshold (i.e. waking up easily) are associated with lower CPAP adherence. Using a randomized controlled trial design, this will be the first study using a targeted intervention to manipulate the underlying OSA causes (i.e., giving a safe hypnotic to patients with OSA to increase the arousal threshold) to test the hypothesis that endotype-targeted therapy increases CPAP-adherence in patients who have low but continued CPAP usage. Ultimately, this strategy may improve the care and outcomes of millions of undertreated OSA patients.

Interventions

  • DRUG Placebo
  • DRUG Eszopiclone 2 mg

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2023-08-31
Est. Completion 2025-10-01
Phase Phase 2

Sponsor

University of California, San Diego

775 total trials

What the Registry Record Tells You About NCT05951023

The ClinicalTrials.gov registry entry for NCT05951023 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05951023 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05951023 about?

NCT05951023 is a clinical study titled "Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP)". More than 10% of the US population have obstructive sleep apnea (OSA). Standard of care is therapy with CPAP (continuous positive airway pressure) which virtually eliminates OSA. However, most patients use CPAP only for part of the night (4-5hours) and about 50% patients discontinue CPAP long-term. ...

What is the current status of trial NCT05951023?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2023-08-31. Estimated completion is 2025-10-01.

What interventions are being tested in trial NCT05951023?

The interventions under investigation include: Placebo (DRUG), Eszopiclone 2 mg (DRUG).

Who is sponsoring clinical trial NCT05951023?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.