The Psychoneuroimmunology of Insomnia

Primary Insomnia Clinical Trial

Official title:

The Psychoneuroimmunology of Insomnia: Response to a Vaccine Challenge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680771
• Other study ID #: RSRB # 19132
• Secondary ID: 1K23NR010408
• Status: Completed
• Phase: N/A
• First received: May 15, 2008
• Last updated: September 14, 2012
• Start date: March 2008
• Est. completion date: July 2010

Study information

• Verified date: September 2012
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Primary Insomnia

Locations

Country	Name	City	State
United States	University of Rochester Sleep Research Laboratory	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 Months after initial vaccination	No

External Links

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