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Consequences of Nocturnal and Daytime Hypoxemia in COPD

This study has been terminated.
Information provided by (Responsible Party):
Northwell Health Identifier:
First received: October 18, 2007
Last updated: November 13, 2015
Last verified: November 2015
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 Intervention
Chronic Obstructive Pulmonary Disease Drug: Oxygen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care

Resource links provided by NLM:

Further study details as provided by Northwell Health:

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

Enrollment: 20
Study Start Date: October 2005
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Northwell Health Identifier: NCT00547456     History of Changes
Other Study ID Numbers: 05.02.097
Study First Received: October 18, 2007
Results First Received: May 27, 2015
Last Updated: November 13, 2015

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on August 18, 2017