Information Processing at Sleep Onset and During Sleep in Patients With Insomnia (COTE)
| Tracking Information | |||||
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| First Received Date ICMJE | May 15, 2008 | ||||
| Last Updated Date | October 18, 2010 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The intent of this study is to assess whether patients with insomnia exhibit an increased level of information processing (as assessed with ERP methods) at sleep onset and during polysomnographically defined sleep. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00680199 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Assess spindle and K-complex density to investigate whether the groups differ with respect to these putative markers of information processing and parse ERP trials in NREM into those with and without spindles and K-complexes in order to investigate their [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Information Processing at Sleep Onset and During Sleep in Patients With Insomnia | ||||
| Official Title ICMJE | Information Processing at Sleep Onset and During Sleep in Patients With Insomnia | ||||
| Brief Summary | Chronic insomnia is thought to occur as a result of hyperarousal. While there is a wealth of data to support this position, there is a lack of research to define how hyperarousal interferes with sleep initiation, maintenance, and the perception of sleep quality and quantity. We propose to use Event-related Potential (ERP) techniques to evaluate information processing at sleep onset and during sleep. ERP measures of information processing have been well established in good sleepers; they have not been, however, applied to the problem of insomnia. The goal of the project is to examine the premise that the occurrence and severity of insomnia is fundamentally related to a neurobiologic preparedness to "attend to" and "identify" environmental stimuli. Following an extensive screening, patients with insomnia and good sleepers will participate in two experimental conditions, requiring that they spend four nights in the sleep laboratory over a two week period. ERP data will be gathered prior to, following, and during sleep. The ultimate objectives for this line of research are to determine 1) if insomnia is associated with a failure to inhibit information processing at sleep onset and/or during sleep, 2) if the failure to inhibit information processing at sleep onset and/or during sleep is associated with the occurrence and/or severity of insomnia symptoms, 3) what brain regions are functioning differently so as to give rise to information processing abnormalities, and 4) the extent to which pharmacologic and/or Cognitive Behavioral treatment for insomnia alters information processing abnormalities and/or the associated brain activity. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Community Sample |
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| Condition ICMJE | Primary Insomnia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | July 2010 | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Psychophysiologic Insomnia (PI) These subjects will meet RDC criteria for Psychophysiologic insomnia. In addition, the complaint of disturbed sleep will have at least one of the following minimal characteristics:
Total Sleep Time (TST) will not exceed 6 hours [unless the Sleep Efficiency (SE) quotient is < 80%] and the problem frequency must be > 4 nights/week (Severe Insomnia) with a problem duration > 6 months (Chronic Insomnia)B . Inclusion Criteria for Good Sleeper Subjects
A These profiles will be evident at both intake (based on retrospective reports) and as an average from the two weeks of baseline diaries (based on prospective sampling). Exclusion Criteria for All Subjects • Unstable medical illness or acute or history of psychiatric illness (except GAD or MDD - Allowed provided that these have resolved and not recurred within 5 years) As ascertained with self report questionnaires, a clinical History, a physical exam and a clinical chemistry profile. To assure that the insomnia is not secondary to these factors
To assure that the insomnia is not secondary to these factors |
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| Gender | Both | ||||
| Ages | 25 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00680199 | ||||
| Other Study ID Numbers ICMJE | RSRB # 20615, R21MH076855 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sara Matteson-Rusby, Psy.D../Primary Investigator, University of Rochester | ||||
| Study Sponsor ICMJE | University of Rochester | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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