Immunological Consequences of Obstructive Sleep Apnea
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | August 18, 2009 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary outcome variable will be mean lymphocyte interferon- ÿ (IFN- ÿ) production at 14 days (measured by ELISA) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00214071 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Mean influenza antibody concentrations (pre- and post-immunization) with standard deviations will be calculated and compared between sleep apnea and control patients. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Immunological Consequences of Obstructive Sleep Apnea | ||||
| Official Title ICMJE | Influence of Obstructive Sleep Apnea on Humoral and Cell-Mediated Vaccine Responses | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Obstructive Sleep Apnea | ||||
| Intervention ICMJE | Biological: Influenza vaccine | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00214071 | ||||
| Other Study ID Numbers ICMJE | 2003-284 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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