CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 74 enrolled
Drug / intervention
Continuous positive airway pressure +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01807897
NCT01807897Phase 4Completed
CompareCT.gov

Oxygen Versus PAP for Treatment of Sleep Apnea in Chronic Heart Failure

VA Office of Research and Development·interventional·Posted Mar 8, 2013·Updated Jan 25, 2023

In Brief

A Phase 4 clinical trial evaluating Continuous positive airway pressure, Nocturnal supplemental oxygen, and 1 other intervention for Heart Failure and Sleep Apnea Syndromes. Completed, enrolled 74 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Sleep Apnea Syndromes
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2013
Enrollment StartJun 23, 2014
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 13.3 years ago

Interventions

Continuous positive airway pressuredevice

Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index

Nocturnal supplemental oxygendevice

Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia

Healthy Lifestyle and Sleep Educationbehavioral

A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle