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Clinical Trials/NCT00716521
NCT00716521
Completed
Phase 1

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

Pfizer1 site in 1 country11 target enrollmentJuly 2008
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ConditionsMethodology Study
Interventionsplacebozolpidem
Drugsplacebozolpidem

Overview

Phase
Phase 1
Intervention
placebo
Conditions
Methodology Study
Sponsor
Pfizer
Enrollment
11
Locations
1
Primary Endpoint
onset to persistent sleep
Status
Completed
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
October 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Pfizer

Eligibility Criteria

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

Arms & Interventions

Placebo

groups of 3-4 subjects for overnight polysomnography assessments

Intervention: placebo

Low dose Zolpidem

Intervention: zolpidem

High dose zolpidem

Intervention: zolpidem

Outcomes

Primary Outcomes

onset to persistent sleep

Time Frame: minutes

Secondary Outcomes

  • awakenings after sleep onset(minutes)

Study Sites (1)

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