Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease.
Verified date | October 2007 |
Source | Rijnstate Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Dutch Health Care Inspectorate |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | transcutaneous PCO2 | |||
Primary | transcutaneous PO2 | |||
Primary | Oxygen saturation | |||
Secondary | Respiratory Disturbance Index | |||
Secondary | Desaturation Index | |||
Secondary | MSLT | |||
Secondary | arterial PO2 | |||
Secondary | arterial PCO2 | |||
Secondary | Hypercapnic Ventilatory Response | |||
Secondary | total sleeping time | |||
Secondary | sleep latency | |||
Secondary | percentage REM- and nREM-sleep of total sleep time | |||
Secondary | number of arousals | |||
Secondary | number of apneas during sleep | |||
Secondary | number of hypopneas during sleep | |||
Secondary | Epworth Sleeping Score | |||
Secondary | Dyspnea Visual Analog Score |
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