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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Methodology Study

Treatments: Drug: zolpidem; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00716521

A9001390

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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11 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

groups of 3-4 subjects for overnight polysomnography assessments

Treatment:

Drug: placebo

Low dose Zolpidem

Experimental group

Treatment:

Drug: zolpidem

High dose zolpidem

Experimental group

Treatment:

Drug: zolpidem