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Sponsors and Collaborators: |
University of Rochester National Institutes of Health (NIH) |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00680771 |
Chronic insomnia affects approximately 8-9% of the population. The prevalence of this disorder rises dramatically across the lifespan, especially so in women. By age 50-59, the prevalence rate is approximately 25% in women as compared to 15% in men.
When it is chronic, insomnia is associated with increased fatigue, cognitive impairment, mood disturbance, physical complaints, diminished quality of life and increased health care consumption. Beyond these sequaelae, there is now considerable evidence that this sleep disorder confers an increased risk for substance abuse and psychiatric illness (especially major depressive disorder). There is also more limited evidence (based on epidemiologic studies or experimental studies in healthy subjects) that insomnia and/or sleep loss may be a risk factor for hypertension and/or cardiovascular disease, glucose homeostasis dysregulation, and increased mortality.
Despite its prevalence and consequences, the pathophysiology of insomnia and, specifically, the pathway by which morbidity risk is conferred, has been relatively unstudied. With respect to medical illness in particular, insomnia may confer risk in several ways, including: 1) an inherent compromise in the restorative/conservative function of sleep, 2) the deleterious effects of "hyperarousal" and/or HPA axis abnormalities on end organ integrity and function, and/or 3) diminished immunocompetence. With respect to the last of these possibilities, there has been a growing interest in the relationship between immune function and normal sleep, sleep loss, sleep deprivation, and clinical disorders such as insomnia and obstructive sleep apnea.
In its simplest form, the following constitutes the protocol to test whether poor sleep has negative health consequences. More specifically, it is a test of whether chronic insomnia is associated with a blunted adaptive immune response to an experimental challenge.
This study will be conducted at the University of Rochester (UR). Subjects will be seen at both the UR Sleep & Neurophysiology Research Laboratory (SNRL) and the UR General Clinical Research Center (GCRC) with blood samples analyzed at the Strong Memorial Hospital (SMH) Clinical Laboratory and duplicate samples stored in the UR Psychoneuroimmunology Laboratory (PNI Lab) until study completion. The Principal Investigator (PI) will be Wilfred R.
Pigeon, PhD of the SNRL.
Condition |
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Primary Insomnia |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Psychoneuroimmunology of Insomnia: Response to a Vaccine Challenge |
Estimated Enrollment: | 60 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Primary Insomnia
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2
Good Sleepers
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Ages Eligible for Study: | 30 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Community Sample
All subjects will be seronegative for Hepatitis B antibodies, medically healthy (or medically stable) and free from: 1) substance abuse problems, 2) Sleep Disorders (other than insomnia) and unstable Psychiatric Disorders, 3) any conditions contraindicated by the vaccine manufacturer, and 4) any history of allergic reactions to vaccines. Their sleep schedule will include a typical bedtime of between 9:00 p.m. and 12:00 a.m. to minimize circadian rhythm influences on the diagnoses of Psychophysiologic Insomnia (PI).
PIs will meet will meet diagnostic criteria for PI, which are set forth in both the International Classification of Sleep Disorders and the Research Diagnostic Criteria (RDC) for PI.
In terms of severity criteria, PIs will also meet the sleep disturbance criteria of the Pittsburgh Sleep Quality Index (PSQI) > 5 and the Insomnia Severity Index (ISI) > 15 (Moderate to Severe Insomnia). In addition, the complaint of disturbed sleep will have at least one of the following minimal characteristics both at intake (based on retrospective reports) and as an average profile from the two weeks of baseline diaries:
Total Sleep Time (TST) will not exceed 6 hours [unless the Sleep Efficiency (SE) quotient is < 80%] and the problem frequency must be > 3 nights/week (Severe Insomnia). We also extend the requirement for problem duration to > 6 months (Chronic Insomnia) as opposed to the one month requirement in the above nosologies.
Finally, during the two weeks in which patients are completing sleep diaries they will also wear wrist actigraphy devices, which produce objective measures of wake and sleep time. In any patient whose actigraphy data vary from their self-reported diary measures of sleep continuity by >60 minutes will be excluded from the study.
GS participants will report that they obtain enough sleep and that their sleep is restorative. This information will be obtained from the web based screening surveys and intake instruments. In addition, 1) retrospective (intake questionnaires) and prospective assessments (sleep diaries and actigraphy) will show that average SL and WASO < 15 minutes and that TST is > 6 hours and 2) these subjects will score < 5 on the ESS, < 5 on the PSQI, and < 7 on the ISI.
Exclusion Criteria for All Subjects
Contact: Emily Erdman, B.A. | 585-275-7147 | emily_erdman@urmc.rochester.edu |
Contact: Heather Kennedy, B.A. | 585-273-2571 | heather_kennedy@urmc.rochester.edu |
United States, New York | |
University of Rochester Sleep Research Laboratory | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Emily Erdman, B.A. 585-275-7147 emily_erdman@urmc.rochester.edu | |
Contact: Heather Kennedy, B.A. 585-4Sleepy Heather_Kennedy@urmc.rochester.edu | |
Sub-Investigator: Jan Moynihan, Ph.D. | |
Sub-Investigator: Michael L Perlis, Ph.D. | |
Sub-Investigator: M. Saleem Ismail, M.D. |
Principal Investigator: | Wilfred R Pigeon, Ph.D. | University of Rochester |
Responsible Party: | University of Rochester ( Wilfred R. Pigeon Ph.D.Primary Investigator ) |
Study ID Numbers: | RSRB # 19132, 1 K23 NR-00000-13 |
Study First Received: | May 15, 2008 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00680771 History of Changes |
Health Authority: | United States: Institutional Review Board |
Primary Insomnia Insomnia Good Sleepers Hep B Vaccine |
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Mental Disorders Nervous System Diseases |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |