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Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167375
First Posted: September 14, 2005
Last Update Posted: February 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
American Academy of Sleep Medicine
Sunovion
Information provided by:
University of Pittsburgh
  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 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sunovion
Investigators
Principal Investigator: Douglas E Moul, M.D., M.P.H University of Pittsburgh
  More Information

ClinicalTrials.gov Identifier: NCT00167375     History of Changes
Other Study ID Numbers: NSLP1
27-CA-04
First Submitted: September 9, 2005
First Posted: September 14, 2005
Last Update Posted: February 15, 2008
Last Verified: February 2008

Keywords provided by University of Pittsburgh:
Insomnia
polysomnography
sleep onset
time series analysis

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs