Consequences of Nocturnal and Daytime Hypoxemia in COPD
This study has been terminated.
Information provided by (Responsible Party):
Rubin Cohen, MD, North Shore Long Island Jewish Health System
First received: October 18, 2007
Last updated: June 3, 2013
Last verified: June 2013
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.
Chronic Obstructive Pulmonary Disease
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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 ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
Decrease in oxygen level when sleeping
Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Oxygen 2-3L Nasal cannula
Hypothesis: Isolated nocturnal hypoxemia contributes to chronic systemic inflammation in COPD by activating circulating neutrophils.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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 ClinicalTrials.gov identifier: NCT00547456
|North Shore LIJ Health System
|New Hyde Park, New York, United States, 11040 |
North Shore Long Island Jewish Health System
||Rubin Cohen, MD
||North Shore LIJ Health System
No publications provided
||Rubin Cohen, MD, MD, North Shore Long Island Jewish Health System
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 18, 2007
||June 3, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2014
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases