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

NCT05951023 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Based on device recorded usage

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
University of California, San Diego

775 total trials

What the finished NCT05951023 record still lists

NCT05951023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

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

NCT05951023 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05951023's enrollment target sits among peer trials

42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05951023, the US trial registry maintained by the National Library of Medicine. NCT05951023 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.