Oxygen Versus PAP for Sleep Apnea in Heart Failure
Condition: Heart Failure; Sleep Apnea Syndromes
MeSH terms: Apnea; Sleep Apnea Syndromes; Heart Failure
Intervention: Continuous positive airway pressure; Nocturnal supplemental oxygen; Healthy Lifestyle and Sleep Education
Intervention description: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index; Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia; A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Continuous positive airway pressure (CPAP) and supplemental oxygen
Masking: Single (Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Failure; Sleep Apnea; Ventricular Ejection Fraction; Exercise Test

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 <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