Consequences of Nocturnal and Daytime Hypoxemia in COPD

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. Identifier: NCT00547456
Recruitment Status : Terminated
First Posted : October 22, 2007
Results First Posted : December 16, 2015
Last Update Posted : December 16, 2015
Information provided by (Responsible Party):
Northwell Health

Brief Summary:
We will determine whether oxygen therapy lowers the level of substances in the blood which cause inflammation, which is one of the adverse effects of COPD and whether oxygen improves overall well being and quality of life as well as sleep quality.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Oxygen Not Applicable

Detailed Description:
Hypothesis: Isolated nocturnal hypoxemia contributes to chronic systemic inflammation in COPD by activating circulating neutrophils.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : October 2005
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Decrease in oxygen level when sleeping
Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Drug: Oxygen
Oxygen 2-3L Nasal cannula

Primary Outcome Measures :
  1. Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation. [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult males or females with a diagnosis of COPD screened for nocturnal desaturation as indicated above.
  • Clinical stability defined by absence of treatment change or need for acute care within the last two months.
  • Weight stable, within 5%, in the previous three months as measured during office visits.
  • Willingness to participate in a clinical study.

Exclusion Criteria:

  • Acute illness within the preceding 2 months.
  • Patients who received systemic glucocorticoid therapy within the past month.
  • Clinical and/or overnight pulse oximetry evidence of obstructive sleep apnea (OSA). The Multivariate Apnea Prediction Questionnaire (MAP) will be given to all patients to assess the likelihood of OSA based on common symptoms of this disorder. While we recognize that this screening instrument was not evaluated specifically in COPD patients, it assesses common signs and symptoms of OSA. This tool has been shown to identify OSA with 95% sensitivity (63). In addition, the ODI 4% will be determined from the overnight pulse oximetry recording. Patients will be excluded if the MAP score is > 0.4 or if the ODI 4% is >15/hour, which is suggestive of the concomitant presence of obstructive sleep apnea.
  • Hypercapnia defined as PaCO2 > 50 mmHg on resting arterial blood gas
  • Previous diagnosis of erythrocytosis, pulmonary vascular disease, pleural effusions, ischemic heart disease or congestive heart failure.
  • No chronic illnesses known to affect the inflammatory response such as infection, collagen vascular disease, liver disease, thyroid disease or diabetes.
  • Primary care or pulmonary physician refusal.
  • Patient refusal for any reason.
  • Lack of capacity to participate in the informed consent process.

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 identifier (NCT number): NCT00547456

United States, New York
North Shore LIJ Health System
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Principal Investigator: Rubin Cohen, MD Northwell Health

Responsible Party: Northwell Health Identifier: NCT00547456     History of Changes
Other Study ID Numbers: 05.02.097
First Posted: October 22, 2007    Key Record Dates
Results First Posted: December 16, 2015
Last Update Posted: December 16, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases