Phase 4
N=74
Oxygen Versus PAP for Sleep Apnea in Heart Failure
Heart Failure · Sleep Apnea Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT01807897 ↗Enrolled (actual)
74
Serious AEs
13.5%
Results posted
Jan 2023
Primary outcome: Primary: Left Ventricular Ejection Fraction — 1.63; 1.69; 4.42 percent of LV diastolic volume
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Continuous positive airway pressure (Device); Nocturnal supplemental oxygen (Device); Healthy Lifestyle and Sleep Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Ejection Fraction |
1.63; 1.69; 4.42 | — |
| SECONDARY Peak Oxygen Consumption (VO2 Peak) |
-0.40; 0.11; -1.54 | — |
| SECONDARY 24-hour Ambulatory Blood Pressure |
87.5; 88.0; 77.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Veteran receiving care within the Veterans Health Administration healthcare system
- Age 18 years
- Physician diagnosis of chronic heart failure, American Heart Association Stage C-D
- LVEF 5 events/hour
Exclusion Criteria
- Hospitalization for acute decompensated HF within previous 30 days
- Hospitalization for myocardial infarction or cardiac surgery within previous 90 days
- Presence of a left ventricular assist device
- History of heart transplantation
- Poorly controlled hypertension (>170/>110)
- Poorly controlled diabetes (HbA1c > 9.0)
- Severe renal failure with estimated glomerular filtration rate <30 ml/min
- Prior stroke with functional impairment or other severe, uncontrolled medical problems that may impair ability to participate in the study exams, based on medical history and review of medical records
- Severe chronic insomnia, with reported usual sleep duration <4 hours
- Severe daytime sleepiness, defined as Epworth Sleepiness Scale score 18 or higher or a report of falling asleep driving during the previous year, and deemed a safety risk by study physician
- Awake resting oxyhemoglobin saturation <89%
- Pregnancy
- Smoking by subject or other person in the subject's bedroom, or other open flame in bedroom
- Current use of a positive airway pressure device (including continuous or bi-level positive airway pressure or adaptive servo-ventilation) or supplemental oxygen therapy
Data sourced from ClinicalTrials.gov (NCT01807897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.