Consequences of Nocturnal and Daytime Hypoxemia in COPD

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Rubin Cohen, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00547456
First received: October 18, 2007
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

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 ]

Enrollment: 20
Study Start Date: October 2005
Estimated Study Completion Date: December 2013
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547456

Locations
United States, New York
North Shore LIJ Health System
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Rubin Cohen, MD North Shore LIJ Health System
  More Information

No publications provided

Responsible Party: Rubin Cohen, MD, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00547456     History of Changes
Other Study ID Numbers: 05.02.097
Study First Received: October 18, 2007
Last Updated: June 3, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014