Immunological Consequences of Obstructive Sleep Apnea

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Biological: Influenza vaccine	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	30 participants
Allocation:	Non-Randomized
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The primary outcome variable will be mean lymphocyte interferon- ÿ (IFN- ÿ) production at 14 days (measured by ELISA)

Secondary Outcome Measures :

1. Mean influenza antibody concentrations (pre- and post-immunization) with standard deviations will be calculated and compared between sleep apnea and control patients.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53719

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:	John M Dopp, PharmD	University of Wisconsin, Madison

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00214071 History of Changes
Other Study ID Numbers:	2003-284
First Posted:	September 21, 2005
Last Update Posted:	October 5, 2015
Last Verified:	August 2009

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms	Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs