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NCT01807897 · ClinicalTrials.gov registry record · Phase 4
Oxygen Versus PAP for Sleep Apnea in Heart Failure
A Phase 4 study of Heart Failure and Sleep Apnea Syndromes, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
- 2
- Study locations
NCT01807897: Completed Phase 4 study of Heart Failure and Sleep Apnea Syndromes, sponsored by VA Office of Research and Development.
NCT01807897 is a Phase 4 study of Heart Failure and Sleep Apnea Syndromes that has completed, run by VA Office of Research and Development. The registered enrollment target is 74 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01807897, a Phase 4 study of Heart Failure and Sleep Apnea Syndromes, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and continuous positive airway pressure (CPAP). The main outcome measures will be left ventricular ejection fraction on echocardiogram and peak oxygen consumption on cardiopulmonary exercise testing.
Primary Outcome
Standard transthoracic 2-dimensional and Doppler echocardiography will be performed. M-mode measurements of LV dimensions will be performed and analyzed according to the American Society of Echocardiography recommendations and LVEF measured using the modified Simpson's method. Measurement is change from baseline in LVEF.
Conditions Studied
Interventions
- DEVICE Continuous positive airway pressure
- DEVICE Nocturnal supplemental oxygen
- BEHAVIORAL Healthy Lifestyle and Sleep Education
Study Locations (2)
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven
Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2014-06-23 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 4 |
What the finished NCT01807897 record still lists
NCT01807897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 3 interventions - of which Continuous positive airway pressure is the first listed.
NCT01807897 reports a single indexed study location in Connecticut, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01807897 about?
NCT01807897 is a clinical study titled "Oxygen Versus PAP for Sleep Apnea in Heart Failure". The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and continuous positive airway press...
What is the current status of trial NCT01807897?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2014-06-23. Estimated completion is 2020-06-30.
What conditions does trial NCT01807897 study?
This clinical trial studies the following conditions: Heart Failure, Sleep Apnea Syndromes.
What interventions are being tested in trial NCT01807897?
The interventions under investigation include: Continuous positive airway pressure (DEVICE), Nocturnal supplemental oxygen (DEVICE), Healthy Lifestyle and Sleep Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01807897?
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 NCT01807897 being conducted?
This trial has 2 study locations across Connecticut, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
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 NCT01807897's enrollment target sits among peer trials
74 238th of 397 higher than 160 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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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