Testing the Nocturnal Sleep Latency Profile in Primary Insomnia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Primary Insomnia Sleep Initiation and Maintenance Disorders	Drug: eszopiclone 3 mg qHS Behavioral: General cognitive/behavioral interventions for insomnia	Phase I

Drug Information available for:

Eszopiclone

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective

Official Title:	Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

Further study details as provided by University of Pittsburgh:

Estimated Enrollment:	24
Study Start Date:	January 2005
Study Completion Date:	June 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167375

Locations


United States, Pennsylvania
	Western Psychiatric Institute and Clinic
	Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

American Academy of Sleep Medicine

Sepracor, Inc.

Investigators


Principal Investigator:	Douglas E Moul, M.D., M.P.H	University of Pittsburgh

More Information

Study ID Numbers:	NSLP1, 27-CA-04
First Received:	September 9, 2005
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00167375
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Insomnia

polysomnography

sleep onset

time series analysis

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders

Mental Disorders

Dyssomnias

Sleep Disorders

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on November 30, 2008

Sponsors and Collaborators:	University of Pittsburgh American Academy of Sleep Medicine Sepracor, Inc.
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00167375