Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
Information source: Pfizer
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Disorder
Intervention: placebo (Drug); zolpidem (Drug); zolpidem (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
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
Study design: Basic Science, Randomized, Single Blind (Subject), Crossover Assignment, Efficacy Study
Primary outcome: onset to persistant sleep
Secondary outcome: awakenings after sleep onset
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2008
Ending date: October 2008
Last updated: August 5, 2008
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