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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.
Hypothesis: Isolated nocturnal hypoxemia contributes to chronic systemic inflammation in COPD by activating circulating neutrophils.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decrease in oxygen level when sleeping | Other | Patients are their own controls and tested pre and post the addition of night time supplemental oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | Oxygen 2-3L Nasal cannula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rubin Cohen, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore LIJ Health System | New Hyde Park | New York | 11040 | United States |
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recruitment details occurred as outlined in protocol
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| ID | Title | Description |
|---|---|---|
| FG000 | Decrease in Oxygen Level When Sleeping | Patients are their own controls and tested pre and post the addition of night time supplemental oxygen Oxygen: Oxygen 2-3L Nasal cannula |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Decrease in Oxygen Level When Sleeping | Patients are their own controls and tested pre and post the addition of night time supplemental oxygen Oxygen: Oxygen 2-3L Nasal cannula |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | participants between the ages of 18-65 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation. | The assay used did not work, as a result, no data for any Outcome Measures was collected. The trial is closed and completed. | Posted | 4 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decrease in Oxygen Level When Sleeping | Patients are their own controls and tested pre and post the addition of night time supplemental oxygen Oxygen: Oxygen 2-3L Nasal cannula |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rubin Cohen, MD | North Shore LIJ Health System | 516-465-5400 | rocohen@nshs.edu |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| nocturnal hypoxemia | Number | participants |
|
| Number of Participants with Nocturnal and Daytime Hypoxemia in COPD | Number | participants |
|
| 0 |
| 20 |
| 0 |
| 20 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |