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

Phase 1

Completed

• Conditions: Methodology Study
• Interventions: Drug: zolpidem; Drug: placebo

• Registration Number: NCT00716521
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-23
• Study Start: 2008-07
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High dose zolpidem	zolpidem	-
Placebo	placebo	groups of 3-4 subjects for overnight polysomnography assessments
Low dose Zolpidem	zolpidem	-

Primary Outcome Measures

Name	Time	Method
onset to persistent sleep	minutes

Secondary Outcome Measures

Name	Time	Method
awakenings after sleep onset	minutes

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States