Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

NCT ID: NCT00167375

Last Updated: 2008-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-06-30

Brief Summary

This study tests a new kind of sleep study in which subjects are awakened 2 times after initially going to sleep. The study focuses on the EEG signal process as a person goes to sleep. The general hypothesis is that the signal properties are stable from night to night during baseline studies, and are different between controls and patients with primary insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia intervention. Then the new kind of study is repeated in the patients. The controls only are examined in baseline studies.

Detailed Description

Patients are carefully screened to have DSM primary insomnia, and do not have another disorder than may cause a sleep disturbance. After a 2-week baseline period, the subjects undergo a screening sleep study to rule out sleep apnea and periodic limb movement disorder. Then they undergo the NSLP procedure. In that procedure, there pre-bedtime EEG recordings and questionnaire responses taken. Then at a planned time, the subjects go to bed and try to sleep while there EEG signals are recorded. After the first and second sleep cycles, they are awakened for one minute, then asked to return to sleep. In the morning additional recordings and questionnaire responses are obtained. Two nights later they repeat a baseline NSLP procedure. The controls then end their participation. The Patients then receive an open treatment with eszopiclone and behavioral treatments so that their insomnia may improve. After 2 weeks intervention, the patients complete one NLSP night. The goal of the study is to see if there can be data to support the idea that the sleep onset process might harbor a sign of primary insomnia that could be used for the development of a better medical model of primary insomnia.

Conditions

Primary Insomnia; Sleep Initiation and Maintenance Disorders

Study Design

• Study Time Perspective: PROSPECTIVE

Interventions

eszopiclone 3 mg qHS

Intervention Type: DRUG

General cognitive/behavioral interventions for insomnia

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Primary Insomnia (N = 12) Age & Gender matched Healthy controls (N = 12)

Exclusion Criteria

• Unstable Medical illness No other Sleep disorder BMI > 35, AHI > 10, PLM Index > 10, Ferritin < 50. Unable to communicate in English

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Academy of Sleep Medicine

OTHER

Sponsor Role: collaborator

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Principal Investigators

Douglas E Moul, M.D., M.P.H

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

27-CA-04

Identifier Type: -

Identifier Source: secondary_id

NSLP1

Identifier Type: -

Identifier Source: org_study_id