Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167375
• Other study ID #: NSLP1
• Secondary ID: 27-CA-04
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: February 13, 2008
• Start date: January 2005
• Est. completion date: June 2007

Study information

• Verified date: February 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• eszopiclone 3 mg qHS

Behavioral:
• General cognitive/behavioral interventions for insomnia

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	American Academy of Sleep Medicine, Sunovion

Country where clinical trial is conducted

United States,