Consequences of Nocturnal and Daytime Hypoxemia in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease
Eligibility 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.
Sites / Locations
- North Shore LIJ Health System
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Decrease in oxygen level when sleeping
Arm Description
Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Outcomes
Primary Outcome Measures
Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00547456
Brief Title
Consequences of Nocturnal and Daytime Hypoxemia in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Hypothesis: Isolated nocturnal hypoxemia contributes to chronic systemic inflammation in COPD by activating circulating neutrophils.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decrease in oxygen level when sleeping
Arm Type
Other
Arm Description
Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
Oxygen 2-3L Nasal cannula
Primary Outcome Measure Information:
Title
Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubin Cohen, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore LIJ Health System
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
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Consequences of Nocturnal and Daytime Hypoxemia in COPD
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