Expired Study
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Rochester, New York 14642


Purpose:

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.


Criteria:

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: - > 30 min. sleep-onset latency (SL) (Initial Insomnia) - > 30 min. of wake after sleep-onset (WASO) (Middle Insomnia) - Early Morning Awakening (EMA) >30 min. prior to the desired wake up time (Late Insomnia) - Any two of the above complaints (Mixed Insomnia) 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 - Undergoing and/or taking immunosuppressive therapies Assessed by self-report and by clinical interview during Intake To exclude patients with medically stable but immune-altering conditions or therapies - Sero-positive for Hep B antibodies Assessed via immunoassay from blood sample taken at intake session To assure that all subjects have not been exposed to Hep B and are naïve to the Hep B vaccine - Inadequate language comprehension Informally assessed by clinical interview during Intake To assure the quality of self report data as all the measures are in English - Menopause, peri-menopause or premenstrual syndrome Assessed by self report and with items on the prospective daily sleep diaries following Intake To increase sample homogeneity and assure that the insomnia is not secondary to these conditions - Pregnancy Assessed by self report and from the clinical chemistries obtained during the screening physical To: 1) prevent the fetus from exposure to the study vaccine (it should be noted that the vaccine is considered FDA pregnancy category C), and 2) control for the biopsychosocial changes that occur with pregnancy and may alter both sleep and/or the antibody response - Unstable medical or psychiatric illness Assessed with the Mini International Neuropsychiatric Interview (MINI) at Intake To assure that the insomnia is not secondary to these factors - History of head injury with a sustained loss of consciousness Assessed by self report during at Intake To help assure that the EEG measures are not confounded by brain damage - Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence Assessed at intake with the MINI and written versions of clinical interview queries regarding alcohol use, abuse, and dependence and the clinical chemistries obtained during the screening physical To assure that the insomnia is not secondary to these factors and to assure that substance use does not confound the response to the Hep B Vaccine - Use of medications thought to alter sleep such as stimulants, sedating antidepressants, and hypnotics Assessed by self report and from the toxicology screen obtained during the screening physical To assure that the immune response effects observed in this study are not due to medication NOTE: Subjects using such medications for sleep will be given the option of participating if and when they choose to taper off such medications in consultation with their prescribing physician. - Symptoms suggestive of sleep disorders other than Psychophysiologic Insomnia Assessed with the Sleep Disorders Symptom checklist at Intake To assure that the insomnia is not secondary to these factors - Polysomnographic data indicating sleep disorders other than Psychophysiologic Insomnia Assessed with PSG To assure that the insomnia is not secondary to these factors


NCT ID:

NCT00680771


Primary Contact:

Principal Investigator
Wilfred R Pigeon, Ph.D.
University of Rochester


Backup Contact:

N/A


Location Contact:

Rochester, New York 14642
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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