Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers

Verified by: Pfizer, April 2009
First Received: June 23, 2008 | Last Updated: April 22, 2009 | Phase: Phase 1 | Start Date: July 2008
Overall Status: Completed | Estimated Enrollment: 11
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This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture...

Brief Summary

Official Title: “Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers”

This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
  • Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

  • Drug: placebo
    • single oral dose placebo
  • Drug: zolpidem
    • single oral dose, 5 mg zolpidem
  • Drug: zolpidem
    • single oral dose, 10 mg zolpidem

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: Placebo
    • groups of 3-4 subjects for overnight polysomnography assessments
  • Experimental: Low dose Zolpidem
  • Experimental: High dose zolpidem

Outcome Measures for this Clinical Trial

Primary Measures

  • onset to persistent sleep
    • Time Frame: minutes
      Safety Issue?: No

Secondary Measures

  • awakenings after sleep onset
    • Time Frame: minutes
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Age 18-55
  • BMI 18-30 kg/m2
  • body weight > 50 kg

Exclusion Criteria:

  • no history of sleep disorder
  • no concurrent medications
  • no alcohol use
  • no medical issues
  • no smoking

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00716521

Study ID Number: A9001390

ClinicalTrials.gov Identifier: NCT00716521

Health Authority: United States: Institutional Review Board

To obtain contact information for a study center near you, click here.

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00716521