Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease

October 31, 2007 updated by: Rijnstate Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, 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.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6800 TA
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
transcutaneous PCO2
transcutaneous PO2
Oxygen saturation

Secondary Outcome Measures

Outcome Measure
Respiratory Disturbance Index
Desaturation Index
MSLT
arterial PO2
arterial PCO2
Hypercapnic Ventilatory Response
total sleeping time
sleep latency
percentage REM- and nREM-sleep of total sleep time
number of arousals
number of apneas during sleep
number of hypopneas during sleep
Epworth Sleeping Score
Dyspnea Visual Analog Score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

  • Principal Investigator: Gerben Stege, MD, Rijnstate Hospital
  • Study Director: Peter J de Bruijn, MD, Rijnstate Hospital
  • Study Director: Richard PN Dekhuijzen, Prof. PhD MD, UMC St. Radboud
  • Study Director: Frank JJ van den Elshout, PhD MD, Rijnstate Hospital
  • Study Director: Yvonne F Heijdra, PhD MD, UMC St. Radboud
  • Study Director: Marjo JT van de Ven, PhD MD, Rijnstate Hospital
  • Study Chair: Petra JE Vos, PhD MD, Rijnstate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

October 27, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Estimate)

November 2, 2007

Last Update Submitted That Met QC Criteria

October 31, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTC-346/050905/Stege

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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