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NCT05589753 · ClinicalTrials.gov registry record · Phase 1

Sleep Disordered Breathing With Opioid Use

A Phase 1 study of Opioid Use and Sleep Apnea, sponsored by VA Office of Research and Development.

Recruiting
Registry status
Phase 1
Development phase
150
Enrollment target
1
Study location

NCT05589753: Recruiting Phase 1 study of Opioid Use and Sleep Apnea, sponsored by VA Office of Research and Development.

NCT05589753 is a Phase 1 study of Opioid Use and Sleep Apnea that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 150 participants, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05589753, a Phase 1 study of Opioid Use and Sleep Apnea, is actively recruiting participants, sponsored by VA Office of Research and Development.

RECRUITING
Registry status
Phase 1
Development phase
150 participants
Enrollment target
1
Study location

Study Summary

There is an increased risk for sleep disordered breathing (SDB), sleep-related hypoventilation and irregular breathing in individuals on chronic prescription opioid medications. Almost 30% of a veteran sleep clinic population had opioid-associated central sleep apnea (CSA). The proposal aims to identity whether oxygen and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in chronic opioid use via different mechanisms. We will study additional clinical parameters like quality of life, sleep and pain in patients with and without opioid use. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea with opioid use. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea.

Primary Outcome

Measures of breathing instability including: Apneic threshold: this is the end-tidal Co2 at which a central apnea closes to a hypopnea is produced.

Interventions

  • DRUG Acetazolamide
  • OTHER Hyperoxia

Study Locations (1)

Michigan

  • John D. Dingell VA Medical Center, Detroit, MI - Detroit

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2019-05-02
Est. Completion 2027-03-31
Phase Phase 1
VA Office of Research and Development

1,668 total trials

What NCT05589753 shows while recruiting

NCT05589753 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower).

The record links to 3 conditions, with Opioid Use appearing as the primary indexed condition, and to 2 interventions - of which Acetazolamide is the first listed.

NCT05589753 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT05589753 about?

NCT05589753 is a clinical study titled "Sleep Disordered Breathing With Opioid Use". There is an increased risk for sleep disordered breathing (SDB), sleep-related hypoventilation and irregular breathing in individuals on chronic prescription opioid medications. Almost 30% of a veteran sleep clinic population had opioid-associated central sleep apnea (CSA). The proposal aims to iden...

What is the current status of trial NCT05589753?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2019-05-02. Estimated completion is 2027-03-31.

What conditions does trial NCT05589753 study?

This clinical trial studies the following conditions: Opioid Use, Sleep Apnea, Sleep Disordered Breathing.

What interventions are being tested in trial NCT05589753?

The interventions under investigation include: Acetazolamide (DRUG), Hyperoxia (OTHER).

Who is sponsoring clinical trial NCT05589753?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05589753 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Opioid Use

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05589753's enrollment target sits among peer trials

150 47th of 105 higher than 55 of 105 other Opioid Use trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Opioid Use 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 NCT05589753, the US trial registry maintained by the National Library of Medicine. NCT05589753 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.