Obstructive sleep apnea syndrome afflicts at least 2 - 4% of adults and is associated with significant morbidity and mortality. Continuous positive airway pressure (CPAP) therapy is the primary treatment for sleep apnea in adults, but non-adherence to CPAP limits its effectiveness. Even with maximal medical therapy, nasal obstruction is common in sleep apnea patients and may hamper both CPAP adherence and efficacy. However, nasal obstruction (turbinate hypertrophy) is surgically correctable, and treatment of nasal obstruction may lead to more successful use of CPAP. The long-term goal of the proposed research is to develop a novel, multi-disciplinary, multi-modal approach to therapy, in order to improve clinically important treatment outcomes for sleep apnea. The short-term objectives of this proposal are to: 1) Quantify the effect of nasal turbinate reduction on the nasal airway;2) Determine whether turbinate reduction increases CPAP use or efficacy;and 3) Determine whether turbinate reduction positively influences CPAP treatment outcomes. We will employ a single-site, randomized, double-blind, sham-placebo-controlled trial to test the hypotheses that turbinate reduction: 1) increases nasal airway cross-sectional area;2) increases mean nightly objective CPAP use;and 3) improves sleep apnea quality of life 3 months after CPAP titration. We will use the radiofrequency turbinate reduction surgical technique, which allows ethical randomization and effective blinding. Three, six, and 12 months after turbinate reduction and CPAP titration we will measure the change in the minimal nasal cross-sectional area, level of CPAP use, and improvement in sleep apnea quality of life. Secondary outcomes will capture this treatment's broader impact on the nose, CPAP, and sleep apnea. If turbinate reduction can be shown to improve sleep apnea outcomes through increased use or efficacy of CPAP therapy, this trial will demonstrate the value and effectiveness of a novel, multi- disciplinary, combined medical-surgical approach to the management of obstructive sleep apnea syndrome.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL084139-05
Application #
8032429
Study Section
Respiratory Integrative Biology and Translational Research Study Section (RIBT)
Program Officer
Twery, Michael
Project Start
2007-04-01
Project End
2013-02-28
Budget Start
2011-03-01
Budget End
2013-02-28
Support Year
5
Fiscal Year
2011
Total Cost
$373,456
Indirect Cost
Name
University of Washington
Department
Otolaryngology
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Balakrishnan, Karthik; James, Kathryn T; Weaver, Edward M (2016) Predicting CPAP Use and Treatment Outcomes Using Composite Indices of Sleep Apnea Severity. J Clin Sleep Med 12:849-54
Levine, Corinna G; Davis, Greg E; Weaver, Edward M (2016) Functional Comorbidity Index in chronic rhinosinusitis. Int Forum Allergy Rhinol 6:52-7
Skirko, Jonathan R; Weaver, Edward M; Perkins, Jonathan A et al. (2015) Change in Quality of Life with Velopharyngeal Insufficiency Surgery. Otolaryngol Head Neck Surg 153:857-64
Kirkham, Erin M; Heckbert, Susan R; Weaver, Edward M (2015) Relationship between Clinical and Polysomnography Measures Corrected for CPAP Use. J Clin Sleep Med 11:1305-12
Levine, Corinna G; Weaver, Edward M (2014) Functional comorbidity index in sleep apnea. Otolaryngol Head Neck Surg 150:494-500
Schwab, Richard J; Badr, Safwan M; Epstein, Lawrence J et al. (2013) An official American Thoracic Society statement: continuous positive airway pressure adherence tracking systems. The optimal monitoring strategies and outcome measures in adults. Am J Respir Crit Care Med 188:613-20
Balakrishnan, Karthik; James, Kathryn T; Weaver, Edward M (2013) Composite severity indices reflect sleep apnea disease burden more comprehensively than the apnea-hypopnea index. Otolaryngol Head Neck Surg 148:324-30
Skirko, Jonathan R; Weaver, Edward M; Perkins, Jonathan A et al. (2013) Validity and responsiveness of VELO: a velopharyngeal insufficiency quality of life measure. Otolaryngol Head Neck Surg 149:304-11
Tsai, Yi-Ju; Ramar, Kannan; Liang, Yao-Jen et al. (2013) Peripheral neuropathology of the upper airway in obstructive sleep apnea syndrome. Sleep Med Rev 17:161-8
Thilen, Stephan R; Bryson, Christopher L; Reid, Robert J et al. (2013) Patterns of preoperative consultation and surgical specialty in an integrated healthcare system. Anesthesiology 118:1028-37

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