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

Pfizer logo

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

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems