NCT01807897

Oxygen Versus PAP for Sleep Apnea in Heart Failure

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Chronic heart failure (HF) is a highly prevalent disease, with a lifetime risk of approximately 20%. Sleep apnea is a common co-morbid condition, occurring in approximately half of patients with chronic HF, and often has predominantly central or mixed obstructive and central characteristics. Although it is associated with increased mortality in patients with HF, sleep apnea is usually asymptomatic and patients are therefore often unwilling to accept standard therapy with positive airway pressure. At the outset of this study, there were three treatment modalities currently recommended by the American Academy of Sleep Medicine for the treatment of predominantly central sleep apnea in HF patients: nocturnal supplemental oxygen (NSO), continuous positive airway pressure (CPAP) and adaptive servo-ventilation (ASV). Recently, ASV was found to increase mortality in patients with heart failure with reduced ejection fraction and central sleep apnea. There are only limited data on the comparative efficacy and tolerability of these three modalities. The present study is designed to compare these modalities with respect to effects on ventricular function, exercise capacity, and other measures of cardiovascular risk.

Conditions

• Heart Failure
• Sleep Apnea Syndromes

Interventions

Type	Name	Description
DEVICE	Continuous positive airway pressure	Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
DEVICE	Nocturnal supplemental oxygen	Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
BEHAVIORAL	Healthy Lifestyle and Sleep Education	A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle

Timeline

• Start date: 2014-06-23
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2013-03-08
• Last updated: 2023-01-25
• Results posted: 2023-01-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study