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OpenTrials
Completed

NCT Number: NCT00716521

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.

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Key information

Conditions

Methodology Study

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

single oral dose placebo

zolpidem

Drug

single oral dose, 5 mg zolpidem

Primary outcomes

  1. onset to persistent sleep

    Time frame: minutes

Secondary outcomes

  1. awakenings after sleep onset

    Time frame: minutes

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 16, 2008
Registry last updated
Apr 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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