Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration - Full Text View

Sponsor:	Umeå University
Information provided by:	Umeå University
ClinicalTrials.gov Identifier:	NCT00338078

Purpose

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.

Condition	Intervention
Heart Failure	Device: nocturnal oxygen treatment from oxygen concentrators

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	62
Study Start Date:	March 1999
Study Completion Date:	December 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	19 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338078

Locations

Sweden
Dept of respiratory medicine
Umeå, Sweden, SE 901 85

Sponsors and Collaborators

Umeå University

Investigators

Principal Investigator:

Karl A Franklin, MD, PhD

Dept Respiratory Medicine, University Hospital, Umeå

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00338078 History of Changes
Other Study ID Numbers:	241/98, dnr 98-165
Study First Received:	June 16, 2006
Last Updated:	July 1, 2008
Health Authority:	Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:

Cheyne-Stokes Respiration
Heart Failure
Respiration Disorders
Respiratory Tract Diseases

Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012