Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease

This study has been completed.
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00245661
First received: October 27, 2005
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Temazepam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • transcutaneous PCO2
  • transcutaneous PO2
  • Oxygen saturation

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 14
Study Start Date: October 2005
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245661

Locations
Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided by Rijnstate Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00245661     History of Changes
Other Study ID Numbers: LTC-346/050905/Stege
Study First Received: October 27, 2005
Last Updated: October 31, 2007
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Rijnstate Hospital:
COPD
respiratory
sleep quality
temazepam
dyspnea

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

ClinicalTrials.gov processed this record on October 23, 2014