Clinical Trials Directory

Trials / Completed

CompletedNCT00680771

The Psychoneuroimmunology of Insomnia

The Psychoneuroimmunology of Insomnia: Response to a Vaccine Challenge

Status
Completed
Phase
Study type
Observational
Enrollment
28 (actual)
Sponsor
University of Rochester · Academic / Other
Sex
Female
Age
30 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2008-03-01
Primary completion
2010-07-01
Completion
2010-07-01
First posted
2008-05-20
Last updated
2012-10-17
Results posted
2012-10-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00680771. Inclusion in this directory is not an endorsement.