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Completed

NCT Number: NCT00338078

Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of respiratory medicine

Umeå, SE 901 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable heart failure with left ventricular dysfunction
  • Cheyne-Stokes respiration with central AHI>15 and obstructive AHI<5

Exclusion criteria

  • Heart infarction within 3 months.
  • Dementia
  • Chronic obstructive pulmonary disease and daytime hypoxemia.

Treatment and study plan

nocturnal oxygen treatment from oxygen concentrators

Device

Primary outcomes

  1. Exercise capacity

  2. Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)

  3. Brain natriuretic peptide (BNP)

Secondary outcomes

  1. Echocardiography

  2. Radionuclide determination of ejection fraction

  3. Mortality and hospitalization for cardiovascular causes (combined and individually)

  4. Hospitality anxiety and depression scale

  5. Epworth sleepiness scale

  6. Karolinska sleepiness scale

  7. Routine lab (haemoglobins, thyroid status, creatinin)

  8. Urinary catecholamines

  9. Urinary cortisol

  10. Polysomnography

  11. Arrhythmias from 24 hour Holter-ECG registration

  12. Heart rate variability

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Important dates

Study start
1999
Study completion
2006
First posted
Jun 20, 2006
Registry last updated
Jul 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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