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

Sponsored by:	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
Sleep Disorder	Drug: placebo Drug: zolpidem	Phase I

MedlinePlus related topics: Sleep Disorders

Drug Information available for: Zolpidem

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Crossover Assignment, Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

onset to persistant 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:	August 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

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9001390
Study First Received:	June 23, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00716521
Health Authority:	United States: Institutional Review Board

Keywords provided by Pfizer:

mobile actigraphy inpatient polysomnography actigraphy ambien

Study placed in the following topic categories:

Zolpidem
Signs and Symptoms
Mental Disorders

Neurologic Manifestations
Sleep Disorders
Healthy

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
GABA Agonists
Hypnotics and Sedatives
Physiological Effects of Drugs

Nervous System Diseases
Central Nervous System Depressants
GABA Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009