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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23NR010408 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Chronic insomnia affects approximately 8-9% of the population. The prevalence of this disorder rises dramatically across the lifespan, especially so in women. 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. 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 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. This study focuses on the last of these possibilities, the relationship between immune function and sleep.
The study compares immune response to a vaccine challenge in two groups: good sleepers and patients with chronic insomnia. The primary study hypothesis is that the insomnia group will have a decreased rate of adaptive immune response to the vaccine challenge than that of the good sleeper group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Primary Insomnia | ||
| 2 | Good Sleepers |
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| Measure | Description | Time Frame |
|---|---|---|
| Positive Antibody Response | Sero-Response to the Hepatitis B vaccine, defined as reaching or exceeding a Hepatitis B surface antigen level of greater than or equal to 10mIU/mL. | 3 Months after initial vaccination |
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Inclusion Criteria:
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 Primary Insomnia (PI).
PIs will also meet the sleep disturbance criteria of the Pittsburgh Sleep Quality Index(PSQI) > 5 and the Insomnia Severity Index (ISI)> 15 and one of the following minimal characteristics both at intake and as an average profile from the two weeks of baseline diaries: > 30 min. sleep-onset latency (SL), > 30 min. of wake after sleep-onset (WASO), Early Morning Awakening >30 min. prior to the desired wake up time, or any two of the above complaints (Mixed Insomnia); Total Sleep Time (TST) < 6 hours [unless the Sleep Efficiency is < 80%] and the problem frequency must be > 3 nights/week; problem duration > 6 months.
Good Sleeper participants will report that they obtain enough sleep and that their sleep is restorative with average SL and WASO < 15 minutes, TST > 6 hours ESS < 5 on the ESS, < 5 on the PSQI, and < 7 on the ISI.
Exclusion Criteria for All Subjects
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Community Sample
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| Name | Affiliation | Role |
|---|---|---|
| Wilfred R Pigeon, Ph.D. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Sleep Research Laboratory | Rochester | New York | 14642 | United States |
There were two study groups, but this did not involve random assignment. Group assignment to either Primary Insomnia or Good Sleeper was based on subjective (sleep diaries and validated instruments)and objective (polysomnography) measures of sleep. Twenty-eight subjects were enrolled.
Pre-menopausal women aged 25-50 with either Primary Insomnia (PI) or Good Sleep (GS) were recruited from posters, flyers, and newspaper advertisements in the Rochester, NY region during the period of 2008-2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Insomnia | Subjects meeting criteria for primary insomnia. |
| FG001 | Good Sleepers | Subjects meeting criteira for Good Sleepers |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Insomnia | patients meeting criteria for primary insomnia. |
| BG001 | Good Sleepers | participants meetoing criteira for Good Sleepers |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Antibody Response | Sero-Response to the Hepatitis B vaccine, defined as reaching or exceeding a Hepatitis B surface antigen level of greater than or equal to 10mIU/mL. | From subjects with complete data only. | Posted | Number | participants | 3 Months after initial vaccination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Insomnia | patients meeting criteria for primary insomnia. |
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Sample size limited by much higher than expected number of otherwise eligible participants having alrady been exposed to Hep B vaccine or virus.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wilfred Pigeon | University of rochester | (585) 275-3374 | Wilfred_pigeon@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Prior Exposure to Hepatitus B Vaccine |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Good Sleepers | participants meetoing criteira for Good Sleepers | 0 | 13 | 0 | 13 |
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| D001523 |
| Mental Disorders |