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 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT00245661
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of COPD, GOLD 3 or 4
* having subjective sleeping problems
* longer latency to falling asleep
* frequent arousals
* excessive daytime sleepiness
* clinical stable health for minimally 6 weeks
Exclusion Criteria:
* usage of some sort of medication that influences sleep in any kind of way (like benzodiazepines, barbiturates, opiates, amfetamines) which can not be discontinued during the study period
* alcohol abuse
* hospitalisation 6 weeks or shorter before enrollment in the study
* hyperreactivity / allergy to benzodiazepines
* history of benzodiazepine-dependence
* myasthenia gravis
* obstructive sleep apnea syndrome (OSAS)
* severe liver failure
* age under 18 years
* participation in another study less than 6 weeks before enrollment
* COPD exacerbation less than 6 weeks before enrollment
* usage of oxygen supplementation at home
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00245661
Study Brief:
Protocol Section:
NCT00245661