- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00167375
Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
February 13, 2008 updated by: University of Pittsburgh
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Western Psychiatric Institute and Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Douglas E Moul, M.D., M.P.H, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
February 15, 2008
Last Update Submitted That Met QC Criteria
February 13, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSLP1
- 27-CA-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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