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

Description

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), continuous positive airway pressure (CPAP), and adaptive servo-ventilation (ASV). The main outcome measures will be left ventricular ejection fraction on echocardiogram and peak oxygen consumption on cardiopulmonary exercise testing.

Study Start Date

June 2014

Estimated Completion Date

September 2017

Interventions

  • Device: Nocturnal supplemental oxygen
  • Behavioral: Healthy Lifestyle and Sleep Education
  • Device: Continuous positive airway pressure
  • Device: Adaptive pressure-support servo-ventilation

Specialties

  • Cardiology: Heart Failure
  • Pulmonology: Apnea/Sleep Disorders

MeSH Terms

  • Continuous Positive Airway Pressure
  • Heart Failure
  • Nocturnal supplemental oxygen
  • Sleep Apnea Syndromes

Study ID

Department of Veterans Affairs -- CLIN-008-12S

Status

Unknown

Trial ID

NCT01807897

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

161

Sponsor

Department of Veterans Affairs

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 90 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
  • 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
VA Connecticut Healthcare System West Haven Campus West Haven CT - West Haven, Connecticut 15.6 miles Henry K Yaggi MD None klar.yaggi@va.gov
VA Boston Healthcare System Jamaica Plain Campus Jamaica Plain MA - Boston, Massachusetts 132.6 miles Daniel J Gottlieb MD MPH 857-203-6375 daniel.gottlieb@va.gov

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