Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00245661
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : November 2, 2007
Information provided by:
Rijnstate Hospital

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 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Temazepam Phase 3

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  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease.
Study Start Date : October 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Temazepam
U.S. FDA Resources

Primary Outcome Measures :
  1. transcutaneous PCO2
  2. transcutaneous PO2
  3. Oxygen saturation

Secondary Outcome Measures :
  1. Respiratory Disturbance Index
  2. Desaturation Index
  3. MSLT
  4. arterial PO2
  5. arterial PCO2
  6. Hypercapnic Ventilatory Response
  7. total sleeping time
  8. sleep latency
  9. percentage REM- and nREM-sleep of total sleep time
  10. number of arousals
  11. number of apneas during sleep
  12. number of hypopneas during sleep
  13. Epworth Sleeping Score
  14. Dyspnea Visual Analog Score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00245661

Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
Sponsors and Collaborators
Rijnstate Hospital
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00245661     History of Changes
Other Study ID Numbers: LTC-346/050905/Stege
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: October 2007

Keywords provided by Rijnstate Hospital:
sleep quality

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action