NCT00245661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2005

Typical duration for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 2, 2007

Status Verified

October 1, 2007

First QC Date

October 27, 2005

Last Update Submit

October 31, 2007

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDrespiratorysleep qualitytemazepamdyspnea

Outcome Measures

Primary Outcomes (3)

  • transcutaneous PCO2

  • transcutaneous PO2

  • Oxygen saturation

Secondary Outcomes (14)

  • Respiratory Disturbance Index

  • Desaturation Index

  • MSLT

  • arterial PO2

  • arterial PCO2

  • +9 more secondary outcomes

Interventions

TemazepamDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 19910177DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSleep Initiation and Maintenance DisordersDyspnea

Interventions

Temazepam

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gerben Stege, MD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

  • Petra JE Vos, PhD MD

    Rijnstate Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

October 1, 2005

Study Completion

August 1, 2007

Last Updated

November 2, 2007

Record last verified: 2007-10

Locations

NL(1)