Nocturnal Oxygen Therapy

June 23, 2005 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Men and women, ages 35 to 70, who had severe chronic obstructive lung disease requiring supplemental oxygen therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Nicholas Anthonisen, University of Manitoba
  • Paul Kvale, Henry Ford Hospital
  • C.Thomas Boylen, University of Southern California
  • David Cugell, Northwestern University
  • Thomas Petty, University of Colorado, Denver
  • Richard Timms, University of California, San Diego
  • George Williams, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1976

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 2002

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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