Oxygen Versus PAP for Sleep Apnea in Heart Failure

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.

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 <45%

- No change in active cardiac medications for 4 weeks prior to randomization

- Ability to provide informed consent

- Moderate to severe central or mixed central and obstructive sleep apnea, defined as an
apnea-hypopnea index (AHI) 15 events per hour, with a central AHI >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