Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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 study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. In contrast, it may result in an beneficiary effect because it positively affects the sleep quality and sleep structure which may result in more alertness and less daytime sleepiness and less dyspnea during the day.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rijnstate Hospital
• Treatments: Temazepam

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