Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease.
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.
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, generalised insomnia and/or excessive daytime sleepiness. Sleep disturbance
seems to be more severe with advancing disease and substantially reduces patients' quality
of life. The sleep complaints are due to dyspnea, chronic cough, sputum production,
hypoxaemia and hypercapnia during the night. One of the available therapies for these
patients is the prescription of hypnotics (like benzodiazepines). However, it is thought
that in patients with COPD sleep medication may produce adverse respiratory effects due to
suppression of the cerebral respiratory drive. In our practice, we never encounter any
adverse respiratory effect of an hypnotic in patients with COPD. There have been several
trials in COPD patients studying these potentially adverse effects. The results of these
studies are inconsistent, relative older hypnotics are used and there are several
methodological limitations. Furthermore, in none of these studies transcutaneous PCO2 or PO2
was monitored. Temazepam is nowadays the sedative of first choice in the medical treatment
of sleep complaints.
Aim: primary: studying the effects of temazepam on the respiratory function during daytime
and at night in patients with severe COPD. Secondary: studying the effects of temazepam on
the sleep quality and sleep structure and on the objective and subjective sleepiness during
daytime and at night in patients with COPD.
Study design: double blind, placebo-controlled, cross-over randomised clinical trial.
Treatment: 10 mg temazepam or placebo during seven consecutive nights.
Endpoints: Primary: difference in PtcCO2, PtcO2 and oxygen saturation during sleep after 1
week temazepam compared to placebo. Secondary: Respiratory Disturbance Index, Desaturation
Index and Hypercapnic Ventilatory Response, percentage REM/nREM-sleep and total effective
sleep time, Multiple Sleep Latency Test and the Epworth Sleeping Score.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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