Status:
COMPLETED
The Psychoneuroimmunology of Insomnia
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Primary Insomnia
Eligibility:
FEMALE
30-50 years
Brief Summary
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 associate...
Eligibility Criteria
Inclusion
- 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
- any conditions contraindicated by the vaccine manufacturer or any history of allergic reactions to vaccines
- Undergoing and/or taking immunosuppressive therapies
- Sero-positive for Hep B antibodies
- Inadequate language comprehension
- Menopause, peri-menopause or premenstrual syndrome
- Pregnancy
- Unstable medical or psychiatric illness
- History of head injury with a sustained loss of consciousness
- Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
- Use of medications thought to alter sleep such as stimulants, sedating antidepressants, and hypnotics
- Symptoms suggestive of sleep disorders other than Insomnia
- Polysomnographic data indicating sleep disorders other than Insomnia
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00680771
Start Date
March 1 2008
End Date
July 1 2010
Last Update
October 17 2012
Active Locations (1)
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1
University of Rochester Sleep Research Laboratory
Rochester, New York, United States, 14642