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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT01072292
Eligibility Criteria:
Inclusion Criteria:
* Subjects will have moderate to severe COPD. Severity of COPD will be defined according to the new GOLD standards (moderate IIA (moderate), 50% \< FEV1 \< 80% predicted; moderate IIB (severe) 30% \< FEV1 \< 50%). 58
* Insomnia. Insomnia will be defined as difficulty initiating or maintaining sleep, waking up too early or poor quality sleep. 59
* Subjects must be \> 45 years of age with no other major health problems
* Subjects must be clinically stable at the time of enrollment into the study without major exacerbation of COPD within the previous two months.
Exclusion Criteria:
* Evidence of restrictive lung disease or asthma.
* Evidence of a major sleep disorder other than insomnia (sleep apnea evidenced by apnea/hypopnea index of \> 10, periodic limb movement disorder, narcolepsy).
* Hypnotic, sedative, anxiolytic or antidepressant use.
* Pulse oximetry (SaO2) reading of \< 90% at rest.
* Pulse oximetry (SaO2) reading of \< 85% at night for \> 5 minutes.
* Significant sleep apnea (apnea/hypopnea index ≥ 10).
* .Acute respiratory infection within the previous 2 months.
* Class \> 2 functional status according to the New York Heart Association.
* The presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.
* A self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of \> 11.
* Currently participating in pulmonary rehabilitation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT01072292
Study Brief:
Protocol Section:
NCT01072292