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Sleep Loss and Mechanisms of Impaired Glucose Metabolism

NCT00555750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-12-10

Study results available
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Summary

The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA.

Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that can be reversed by two months of eszopiclone for the primary insomnia

Conditions

  • Primary Insomnia

Interventions

DRUG

eszopiclone

3mg tablet, by mouth nightly 30 min before bed, for two months

DRUG

placebo

inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY

  • Mclean Hospital

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • John W Winkelman, MD, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555750 on ClinicalTrials.gov