Sleep Loss and Mechanisms of Impaired Glucose Metabolism

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Mclean Hospital; National Center for Research Resources (NCRR); Sunovion
• Treatments: Eszopiclone

Criteria

Inclusion Criteria:

• Age 25-55

• Complaint of insomnia of at least 6 months duration

• DSM-IV diagnosis of Primary Insomnia

• Sleep diary: mean Total Sleep Time < 6 hours and a mean total wake time (sleep latency + wake after sleep onset) of greater than 60 minutes (in previous 14 days as recorded on sleep diary)

• A willingness to comply with study procedures

• If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, and intrauterine device [IUD])

Exclusion Criteria:

• Current diagnosis of DSM-IV Axis I disorder other than Primary Insomnia

• Regular treatment (more than 1 time/week) with CNS active medication within 1 month of fist inpatient visit

• Treatment with medications that interfere with glucose metabolism including anti-diabetic medications or steroidal contraceptives

• Uncontrolled medical illness that would interfere with participation in the study

• Body Mass Index >32 or <19.8

• Current symptoms or diagnosis of any moderate to severe sleep disorder other than insomnia

• No menopausal or peri-menopausal symptoms that disrupt sleep

• Pregnant, lactating or planning to become pregnant

• Consumption of > 2 caffeinated beverages per day (including coffee, tea and/or other caffeine-containing beverages or food) during 3 weeks prior to the start of the study