Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease

NCT ID: NCT00245661

Last Updated: 2007-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-08-31

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; respiratory; sleep quality; temazepam; dyspnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Temazepam

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Gerben Stege, MD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Peter J de Bruijn, MD

Role: STUDY_DIRECTOR

Rijnstate Hospital

Richard PN Dekhuijzen, Prof. PhD MD

Role: STUDY_DIRECTOR

UMC St. Radboud

Frank JJ van den Elshout, PhD MD

Role: STUDY_DIRECTOR

Rijnstate Hospital

Yvonne F Heijdra, PhD MD

Role: STUDY_DIRECTOR

UMC St. Radboud

Marjo JT van de Ven, PhD MD

Role: STUDY_DIRECTOR

Rijnstate Hospital

Petra JE Vos, PhD MD

Role: STUDY_CHAIR

Rijnstate Hospital

Locations

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Countries

Netherlands

References

Stege G, Heijdra YF, van den Elshout FJ, van de Ven MJ, de Bruijn PJ, van Sorge AA, Dekhuijzen PN, Vos PJ. Temazepam 10mg does not affect breathing and gas exchange in patients with severe normocapnic COPD. Respir Med. 2010 Apr;104(4):518-24. doi: 10.1016/j.rmed.2009.10.022. Epub 2009 Nov 12.

Reference Type: DERIVED

PMID: 19910177 (View on PubMed)

Related Links

http://www.alysis.nl/site/index_html

sponsor's web site

Other Identifiers

LTC-346/050905/Stege

Identifier Type: -

Identifier Source: org_study_id