The Psychoneuroimmunology of Insomnia
|ClinicalTrials.gov Identifier: NCT00680771|
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : October 17, 2012
Last Update Posted : October 17, 2012
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||28 participants|
|Official Title:||The Psychoneuroimmunology of Insomnia: Response to a Vaccine Challenge|
|Study Start Date :||March 2008|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
- Positive Antibody Response [ Time Frame: 3 Months after initial vaccination ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680771
|United States, New York|
|University of Rochester Sleep Research Laboratory|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Wilfred R Pigeon, Ph.D.||University of Rochester|