Measuring Effectiveness in Sleep Apnea Surgery

The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP.

The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP. We propose to measure the impact of surgical OSA treatment on these health-related and functional outcomes measures with the following three analyses: (1) to assess the changes seen with surgical treatment; (2) to compare changes seen with surgical and PAP treatment; and (3) to evaluate the association between changes in respiratory patterns during sleep and changes in health-related and functional outcomes measures for both surgical and PAP treatment.

Surgical OSA Treatment Group: Moderate to Severe OSA patients who are unable to tolerate PAP (Positive Airway Pressure) and elect to proceed with surgical treatment (surgical cohort).

Positive Airway Pressure Therapy Comparison Group: Moderate to Severe OSA patients who tolerate PAP (Positive Airway Pressure).

Leptin, Homocysteine, Homeostasis model of insulin resistance (HOMA-IR), Heart rate variability, Functional Outcomes of Sleep Questionnaire and Psychomotor Vigilance Task.

Inclusion Criteria (Surgical Group) Unable to tolerate PAP, supported by statement from sleep physician Multilevel airway obstruction Elect to proceed with surgical OSA treatment (uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension) Inclusion Criteria (Comparison Group-PAP) Tolerance of PAP during titration study and indication of willingness to use No previous treatment of PAP except during titration study Washout period of two weeks between PAP titration study and study assessment Matched to surgical group patient on age, gender, race, body mass index, and OSA disease severity (apnea-hypopnea index) Exclusion Criteria: Pregnant women Primary snoring or mild OSA (apnea-hypopnea index < 15) Known neurologic, cardiac, hepatic, or renal disorder Acute illness or infection Co-existing sleep disorder other than primary snoring Unable to fast overnight prior to blood draw

Kezirian EJ, Malhotra A, Goldberg AN, White DP. Changes in obstructive sleep apnea severity, biomarkers, and quality of life after multilevel surgery. Laryngoscope. 2010 Jul;120(7):1481-8. doi: 10.1002/lary.20946.