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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00716521

Enrollment

Registered

2008-07-16

Start date

2008-07-31

Completion date

2008-10-31

Last updated

2009-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methodology Study

Keywords

mobile actigraphy inpatient polysomnography actigraphy ambien

Brief 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.

Interventions

DRUGplacebo

single oral dose placebo

DRUGzolpidem

single oral dose, 5 mg zolpidem

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
onset to persistent sleep	minutes

Secondary

Measure	Time frame
awakenings after sleep onset	minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026