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

Pfizer11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Methodology Study

Interventions

placeboDRUG

single oral dose placebo

zolpidemDRUG

single oral dose, 5 mg zolpidem

zolpidemDRUG

single oral dose, 10 mg zolpidem

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

onset to persistent sleep

Time frame: minutes

Secondary Outcomes

awakenings after sleep onset

Time frame: minutes

Data from ClinicalTrials.gov

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