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NCT04118387 · ClinicalTrials.gov registry record · Phase 4
Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment
A Phase 4 study of Sleep Disordered Breathing and Able Bodied, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04118387: Recruiting Phase 4 study of Sleep Disordered Breathing and Able Bodied, sponsored by VA Office of Research and Development.
NCT04118387 is a Phase 4 study of Sleep Disordered Breathing and Able Bodied that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 200 participants, roughly in line with the 188-participant average among 19 other Sleep Disordered Breathing trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04118387, a Phase 4 study of Sleep Disordered Breathing and Able Bodied, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Central sleep apnea (CSA) is common in patients with heart failure and those using opioid analgesics. Unfortunately, effective treatment of central apnea remains elusive, pressure therapy given the modest efficiency of positive airway pressure therapy. The focus of this proposal is to identify mechanistic pathways to guide future therapeutic interventions for central sleep apnea based on the strong premise that multi-modality therapy will normalize respiration and hence mitigate adverse long-term consequences of CSA. The investigators' proposed studies will test combination therapies, including positive airway pressure (PAP) plus a pharmacological agent who have heart failure or are using opioid analgesics. The investigators anticipate that findings will inform future clinical trials to improve care and quality of life among Veterans suffering from central sleep apnea, which remains difficult to treat using existing approaches.
Primary Outcome
CO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative.
Conditions Studied
Interventions
- DRUG Acetazolamide + supplemental oxygen + PAP therapy
- DRUG Zolpidem + PAP therapy
- DRUG Buspirone + PAP therapy
Study Locations (1)
Michigan
- John D. Dingell VA Medical Center, Detroit, MI - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-01-07 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
What NCT04118387 shows while recruiting
NCT04118387 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 188-participant average among 19 other Sleep Disordered Breathing trials with a reported enrollment target.
The record links to 2 conditions, with Sleep Disordered Breathing appearing as the primary indexed condition, and to 3 interventions - of which Acetazolamide + supplemental oxygen + PAP therapy is the first listed.
NCT04118387 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04118387 about?
NCT04118387 is a clinical study titled "Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment". Central sleep apnea (CSA) is common in patients with heart failure and those using opioid analgesics. Unfortunately, effective treatment of central apnea remains elusive, pressure therapy given the modest efficiency of positive airway pressure therapy. The focus of this proposal is to identify mecha...
What is the current status of trial NCT04118387?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2021-01-07. Estimated completion is 2026-12-31.
What conditions does trial NCT04118387 study?
This clinical trial studies the following conditions: Sleep Disordered Breathing, Able Bodied.
What interventions are being tested in trial NCT04118387?
The interventions under investigation include: Acetazolamide + supplemental oxygen + PAP therapy (DRUG), Zolpidem + PAP therapy (DRUG), Buspirone + PAP therapy (DRUG).
Who is sponsoring clinical trial NCT04118387?
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 NCT04118387 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Disordered Breathing
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 NCT04118387's enrollment target sits among peer trials
200 4th of 19 higher than 16 of 19 other Sleep Disordered Breathing trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Disordered Breathing 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.
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