Clinical Trial: Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study

Brief Summary: The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.

Detailed Summary: Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.
Sponsor: Umeå University

Current Primary Outcome:

  • Exercise capacity
  • Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
  • Brain natriuretic peptide (BNP)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Echocardiography
  • Radionuclide determination of ejection fraction
  • Mortality and hospitalization for cardiovascular causes (combined and individually)
  • Hospitality anxiety and depression scale
  • Epworth sleepiness scale
  • Karolinska sleepiness scale
  • Routine lab (haemoglobins, thyroid status, creatinin)
  • Urinary catecholamines
  • Urinary cortisol
  • Polysomnography
  • Arrhythmias from 24 hour Holter-ECG registration
  • Heart rate variability


Original Secondary Outcome:

  • Echocardiography
  • Radionucleid determination of ejection fraction
  • Mortality and hospitalization for cardiovascular causes (combined and individually)
  • Hospitality anxiety and depression scale
  • Epworth sleepiness scale
  • Karolinska sleepiness scale
  • Routine lab (haemoglobins, thyroid status, kreatinin)
  • Urinary cathecolamines
  • Urinary cortisol
  • Polysomnography
  • Arrhythmias from 24 hour Holter-ECG registration
  • Heart rate variability


Information By: Umeå University

Dates:
Date Received: June 16, 2006
Date Started: March 1999
Date Completion:
Last Updated: July 1, 2008
Last Verified: June 2008