Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00716521

Purpose

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.

Condition	Intervention	Phase
Methodology Study	Drug: placebo Drug: zolpidem	Phase I

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

Resource links provided by NLM:

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

onset to persistent sleep [ Time Frame: minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

awakenings after sleep onset [ Time Frame: minutes ] [ Designated as safety issue: No ]

Enrollment:	11
Study Start Date:	July 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator groups of 3-4 subjects for overnight polysomnography assessments	Drug: placebo single oral dose placebo
Low dose Zolpidem: Experimental	Drug: zolpidem single oral dose, 5 mg zolpidem
High dose zolpidem: Experimental	Drug: zolpidem single oral dose, 10 mg zolpidem

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716521

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
ClinicalTrials.gov Identifier:	NCT00716521 History of Changes
Other Study ID Numbers:	A9001390
Study First Received:	June 23, 2008
Last Updated:	April 22, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Pfizer:

mobile actigraphy inpatient polysomnography actigraphy ambien

Additional relevant MeSH terms:

Zolpidem
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 02, 2010