Status:
COMPLETED
Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease
Lead Sponsor:
Rijnstate Hospital
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease. The st...
Detailed Description
Rationale: More than 50% of patients with chronic obstructive pulmonary disease (COPD) have sleep complaints characterised by longer latency to falling asleep, more frequent arousals and awakenings, g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00245661
Start Date
October 1 2005
End Date
August 1 2007
Last Update
November 2 2007
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA