Immunological Consequences of Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214071
First received: September 13, 2005
Last updated: August 18, 2009
Last verified: August 2009

September 13, 2005
August 18, 2009
October 2004
June 2006   (final data collection date for primary outcome measure)
The primary outcome variable will be mean lymphocyte interferon- ÿ (IFN- ÿ) production at 14 days (measured by ELISA)
Same as current
Complete list of historical versions of study NCT00214071 on ClinicalTrials.gov Archive Site
Mean influenza antibody concentrations (pre- and post-immunization) with standard deviations will be calculated and compared between sleep apnea and control patients.
Same as current
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Immunological Consequences of Obstructive Sleep Apnea
Influence of Obstructive Sleep Apnea on Humoral and Cell-Mediated Vaccine Responses

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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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Obstructive Sleep Apnea
Biological: Influenza vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Absence of any immunocompromising diseases or medical conditions
  • Not taking any immune modifying medications or supplements
  • Significant obstructive sleep apnea as verified by complete overnight polysomnography with apnea-hypopnea index (AHI) > 15 events per hour (sleep apnea subjects)
  • Free of sleep disordered breathing verified by complete overnight polysomnography (AHI < 5 events per hour) or oximetry (< 5 desaturations per hour) (control subjects)

Exclusion Criteria:

  • Documented history of allergy to influenza vaccine or any of its components
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214071
2003-284
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University of Wisconsin, Madison
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Principal Investigator: John M Dopp, PharmD University of Wisconsin, Madison
University of Wisconsin, Madison
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP