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Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
This study has been completed.
Study NCT00167375   Information provided by University of Pittsburgh
First Received: September 9, 2005   Last Updated: February 13, 2008   History of Changes

September 9, 2005
February 13, 2008
January 2005
 
 
 
Complete list of historical versions of study NCT00167375 on ClinicalTrials.gov Archive Site
 
 
 
Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

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.

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.

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

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
24
June 2007
 

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167375
 
NSLP1, 27-CA-04
University of Pittsburgh
  • American Academy of Sleep Medicine
  • Sepracor, Inc.
Principal Investigator: Douglas E Moul, M.D., M.P.H University of Pittsburgh
University of Pittsburgh
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP