Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT00547456
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00547456
Study Brief:
Protocol Section:
NCT00547456