We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Nocturnal Oxygen Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000564
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : June 24, 2005
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To compare the efficacy of long-term use of nocturnal oxygen therapy (12 hours) with that of continuous, low-flow oxygen therapy (24 hours) in patients with chronic hypoxic lung disease.

Condition or disease Intervention/treatment Phase
Lung Diseases Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease Procedure: oxygen inhalation therapy Phase 3

Detailed Description:


Chronic obstructive pulmonary disease is a major health problem in the United States. In 1975, it was the sixth leading cause of death. The economic impact of the disease in 1972 amounted to $803 million in the direct costs of disability treatment, $3.05 billion in disability costs, and $645 million in lost earnings due to premature death.

Motivated in part by the significant toll of this disease, a conference on the Scientific Basis of Respiratory Therapy, co-sponsored by the American Thoracic Society and the Division of Lung Diseases, examined the current status of the use of oxygen therapy in chronic lung disease. The proceedings of the conference, published in the American Review of Respiratory Disease (Vol. 110, No. 6, December 1974), included a recommendation for clinical studies that would provide a critical assessment of the role of nocturnal oxygen therapy in the treatment of patients with chronic obstructive pulmonary disease. Low-flow oxygen, administered continuously, was known to benefit some patients with chronic hypoxic lung disease. However, low-flow oxygen administration for long periods of time is cumbersome, confining, and expensive. If nocturnal oxygen administration could be unequivocally demonstrated to be efficacious, then the advantages of convenience and cost would have a favorable impact on treatment of patients, and a rationale could be developed for testing this therapy in a larger group of patients.

The Planning Phase of the trial was initiated in September 1976. Patient recruitment began in May 1977. The Recruitment Phase lasted 24 months. The 203 patients in the trial were assigned randomly to nocturnal oxygen therapy (home) or continuous low-flow oxygen therapy.


Randomized, fixed sample. Two hundred and three patients were randomly assigned to at-home treatments of continuous oxygen therapy or nocturnal oxygen therapy. Endpoints related to quality of life, neuropsychological function, and respiratory function and capacity. Intervention lasted for 6 months to 3 years, with an average intervention of 19.3 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : July 1976

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Men and women, ages 35 to 70, who had severe chronic obstructive lung disease requiring supplemental oxygen therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000564

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Layout table for investigator information
OverallOfficial: Nicholas Anthonisen University of Manitoba
OverallOfficial: C.Thomas Boylen University of Southern California
OverallOfficial: David Cugell Northwestern University
OverallOfficial: Paul Kvale Henry Ford Hospital
OverallOfficial: Thomas Petty University of Colorado, Denver
OverallOfficial: Richard Timms University of California, San Diego
OverallOfficial: George Williams The Cleveland Clinic
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00000564    
Other Study ID Numbers: 202
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2002
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Chronic Disease
Disease Attributes
Pathologic Processes