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

Methodology Study Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716521
• Other study ID #: A9001390
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2008
• Last updated: April 22, 2009
• Start date: July 2008
• Est. completion date: October 2008

Study information

• Verified date: April 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Methodology Study

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	onset to persistent sleep		minutes	No
Secondary	awakenings after sleep onset		minutes	No

External Links

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