Testing the Nocturnal Sleep Latency Profile in Primary Insomnia

This study has been completed.
Sponsor:
Collaborators:
American Academy of Sleep Medicine
Sunovion
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00167375
First received: September 9, 2005
Last updated: February 13, 2008
Last verified: February 2008
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sunovion
Investigators
Principal Investigator: Douglas E Moul, M.D., M.P.H University of Pittsburgh
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014