Chronic Obstructive Pulmonary Disease
Conditions
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.
Interventions
DRUGOxygen
Oxygen 2-3L Nasal cannula
Sponsors
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation. | 4 weeks |
Countries
United States
Participant flow
Recruitment details
recruitment details occurred as outlined in protocol
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Decrease in Oxygen Level When Sleeping |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 50 years |
| nocturnal hypoxemia | 20 participants |
| Number of Participants with Nocturnal and Daytime Hypoxemia in COPD | 20 participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.
Time frame: 4 weeks
Population: The assay used did not work, as a result, no data for any Outcome Measures was collected. The trial is closed and completed.