Trial Information
Influence of Obstructive Sleep Apnea on Humoral and Cell-Mediated Vaccine Responses
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
The primary outcome variable will be mean lymphocyte interferon- ÿ (IFN- ÿ) production at 14 days (measured by ELISA)
Principal Investigator
John M Dopp, PharmD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Institutional Review Board
Study ID:
2003-284
NCT ID:
NCT00214071
Start Date:
October 2004
Completion Date:
June 2006
Related Keywords:
- Obstructive Sleep Apnea
- Apnea
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
Name | Location |
University of Wisconsin |
Madison,, Wisconsin 53792-5666 |