Nocturnal Oxygen Therapy

• ClinicalTrials.gov Identifier: NCT00000564
• Recruitment Status: Completed
• First Posted: October 28, 1999
• Last Update Posted: June 24, 2005
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Study Description

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:

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 Design

• Study Type: Interventional (Clinical Trial)
• Allocation: Randomized
• Primary Purpose: Treatment
• Study Start Date: July 1976

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• 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

More Information

Publications:

Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.

Is 12-hour oxygen as effective as 24-hour oxygen in advanced chronic obstructive pulmonary disease with hypoxemia? (The nocturnal oxygen therapy trial--NOTT). Chest. 1980 Sep;78(3):419-20. doi: 10.1378/chest.78.3.419. No abstract available.

DeMets DL, Williams GW, Brown BW Jr. A case report of data monitoring experience: the nocturnal oxygen therapy trial. Control Clin Trials. 1982 Jun;3(2):113-24. doi: 10.1016/0197-2456(82)90039-3.

Heaton RK, Grant I, McSweeny AJ, Adams KM, Petty TL. Psychologic effects of continuous and nocturnal oxygen therapy in hypoxemic chronic obstructive pulmonary disease. Arch Intern Med. 1983 Oct;143(10):1941-7.

Jacques J, Cooney TP, Silvers GW, Petty TL, Wright JL, Thurlbeck WM. The lungs and causes of death in the nocturnal oxygen therapy trial. Chest. 1984 Aug;86(2):230-3. doi: 10.1378/chest.86.2.230.

Williams GW, Snedecor SM, DeMets DL. Recruitment experience in the Nocturnal Oxygen Therapy Trial. Control Clin Trials. 1987 Dec;8(4 Suppl):121S-130S. doi: 10.1016/0197-2456(87)90015-8.

• ClinicalTrials.gov Identifier: NCT00000564
• Other Study ID Numbers: 202
• First Posted: October 28, 1999
• Last Update Posted: June 24, 2005
• Last Verified: May 2002

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes