Immunological Consequences of Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT00214071|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 5, 2015
Obstructive sleep apnea (OSA) is a medical problem whose importance is increasing in recognition and awareness. OSA is associated with the development of hypertension and other cardiovascular diseases (1,2). OSA has pathophysiologic characteristics that are known to negatively impact immune function. Both sleep deprivation and hypoxia, hallmarks of OSA, impair immune responses (6,8,11). In addition, patients with OSA are frequently obese and obesity may be associated with increased chance of infections and immune impairment (14,15). Adipose cells are known to secrete cytokines and hormones that are involved in the immune response such as leptin, tumor necrosis factor alpha and interleukin-6 (16-19). Thus, it seems very likely that OSA may impact antigen-specific immune responses. Although it is known that characteristics of OSA impact immune function, it is not known what effects clinical OSA has on immunity.
The central hypothesis of this application is that that patients with obstructive sleep apnea will have attenuated cell-mediated and humoral immune responses to influenza vaccine compared to matched control subjects. Our hypothesis has been formulated on the basis that patients with OSA are sleep deprived and experience repeated hypoxemia that negatively impact both humoral and cell-mediated immune responses.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Biological: Influenza vaccine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Influence of Obstructive Sleep Apnea on Humoral and Cell-Mediated Vaccine Responses|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
- The primary outcome variable will be mean lymphocyte interferon- ÿ (IFN- ÿ) production at 14 days (measured by ELISA)
- Mean influenza antibody concentrations (pre- and post-immunization) with standard deviations will be calculated and compared between sleep apnea and control patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214071
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53719|
|Principal Investigator:||John M Dopp, PharmD||University of Wisconsin, Madison|