An observational study in Primary Insomnia, sponsored by University of Rochester. Completed at 1 site in United States. Open to female participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-17.
Sponsored by University of Rochester · Observational
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 28 is below the median of 128 across 191 observational studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Community Sample
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
Primary Insomnia
Good Sleepers
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.
Time frame: 3 Months after initial vaccination
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.
| Milestone | Primary Insomnia | Good Sleepers |
|---|---|---|
| Started | 15 | 13 |
| Completed | 9 | 11 |
| Not completed | 6 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Sleep apnea suspected after psg | 1 | 0 |
| Withdrew: Prior exposure to hepatitus b vaccine | 4 | 2 |
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.
| participants | Primary Insomnia | Good Sleepers |
|---|---|---|
| Positive Antibody Response | 7 | 7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary Insomnia | — | 0/15 (0%) | 0/15 (0%) |
| Good Sleepers | — | 0/13 (0%) | 0/13 (0%) |
| Age, Categorical(Participants) | Primary Insomnia | Good Sleepers | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 13 | 28 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Primary Insomnia | Good Sleepers | Total |
|---|---|---|---|
| Female | 15 | 13 | 28 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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University of Rochester