NCT00716521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

April 24, 2009

Status Verified

April 1, 2009

Enrollment Period

3 months

First QC Date

June 23, 2008

Last Update Submit

April 22, 2009

Conditions

Methodology Study

Keywords

mobile actigraphy inpatient polysomnography actigraphy ambien

Outcome Measures

Primary Outcomes (1)

  • onset to persistent sleep

    minutes

Secondary Outcomes (1)

  • awakenings after sleep onset

    minutes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

groups of 3-4 subjects for overnight polysomnography assessments

Drug: placebo

Low dose Zolpidem

EXPERIMENTAL
Drug: zolpidem

High dose zolpidem

EXPERIMENTAL
Drug: zolpidem

Interventions

placeboDRUG

single oral dose placebo

Placebo
zolpidemDRUG

single oral dose, 5 mg zolpidem

Low dose Zolpidem

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55
  • BMI 18-30 kg/m2
  • body weight \> 50 kg

You may not qualify if:

  • no history of sleep disorder
  • no concurrent medications
  • no alcohol use
  • no medical issues
  • no smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Interventions

Zolpidem

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2008

First Posted

July 16, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

April 24, 2009

Record last verified: 2009-04

Locations

US(1)