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NCT02264353 · ClinicalTrials.gov registry record · Phase 4

The Impact of Arousal Threshold in Obstructive Sleep Apnea

A Phase 4 study, sponsored by University of California, San Diego.

Completed
Registry status
Phase 4
Development phase
44
Enrollment target

NCT02264353: Completed Phase 4 study, sponsored by University of California, San Diego.

NCT02264353 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02264353, a Phase 4 study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
Phase 4
Development phase
44 participants
Enrollment target

Study Summary

The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.

Primary Outcome

The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value indicates more severe sleep apnea

Interventions

  • DRUG placebo
  • DRUG Donepezil

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2014-09
Est. Completion 2015-05
Phase Phase 4
University of California, San Diego

775 total trials

What the finished NCT02264353 record still lists

NCT02264353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

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

NCT02264353 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02264353 about?

NCT02264353 is a clinical study titled "The Impact of Arousal Threshold in Obstructive Sleep Apnea". The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold coul...

What is the current status of trial NCT02264353?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2014-09. Estimated completion is 2015-05.

What interventions are being tested in trial NCT02264353?

The interventions under investigation include: placebo (DRUG), Donepezil (DRUG).

Who is sponsoring clinical trial NCT02264353?

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 NCT02264353's enrollment target sits among peer trials

44 1363rd of 2000 higher than 630 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT02264353, the US trial registry maintained by the National Library of Medicine. NCT02264353 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.