2/15/2014 Oral Pressure Therapy for OSA Oral Pressure Therapy for OSA - Disclosures Richard J. Schwab, M.D. • NIH grants - RO1/PPG (Obesity and OSA) Professor of Medicine Division of Sleep Medicine • Consultant: Pulmonary, Allergy and Critical Care Division • Apnicure - Winx TM device University of Pennsylvania Medical Center • Foramis Medical Group Philadelphia, Pennsylvania Introduction Winx TM (OPT) Device • OPT has been shown to effectively treat sleep • A novel oral pressure therapy (OPT) system (Winx TM , apnea in about 40% of patients (Colrain IM et al. ApniCure, Inc.) provides negative pressure to the oral cavity Sleep Medicine 14; 830–837, 2013) Console Mouth Piece 1
2/15/2014 AHI by Severity: Analysis Cohort (n=63) AHI and ODI: Responder Cohort (n=26) Examining the Mechanism of Action of a New Device Study Objectives and Design Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea • Objective of the study was to explore the Schwab et al, submitted to sleep (conditionally mechanism of action of the OPT (oral pressure therapy) device accepted) • Case series study of 15 responders (13 men, 2 Winx TM Device women) and 4 nonresponders (3 men) with sleep apnea. In the responders the mean AHI was 38.5 ± 23.3 events/hour before the OPT device was applied and was reduced to 6.7 ± 5.0 events/hour with the OPT device • All subjects underwent a MRI to examine the biomechanical changes associated with the OPT device 2
2/15/2014 Demographic Information for OPT Subjects Hypotheses With the application of oral pressure therapy Responders Non-Responders Characteristic p* (n=15) (n=4) (OPT): • Mean, minimum and maximum airway area in Age, mean ± SD 58.1 ± 7.7 48.0 ± 8.2 0.1133 the retropalatal region would increase BMI, mean ± SD 30.9 ± 4.0 32.9 ± 3.6 0.2621 • Retropalatal anterior-posterior and lateral airway dimensions would increase Male, N (%) 13 (87%) 3 (75%) 0.5304 • Retroglossal airway dimensions would not AHI at Baseline, mean ± SD 38.5 ± 23.3 24.3 ± 19.4 0.2208 change AHI on Device, mean ± SD 6.7 ± 5.0 27.9 ± 24.0 0.0093 • 3-dimensional centroid of the soft palate and AHI Change, mean ± SD -31.9 ± 20.2 3.6 ± 14.9 0.0059 anterior segment of the tongue would move anteriorly and superiorly *p-value from Fisher’s exact test (for categorical variable) or Wilcoxon two-sample exact test (for continuous variables) comparing responders and non-responders Methods: OPT Application 3D Image Analysis Magnetic Resonance Imaging (1.5T) BASELINE WITH OPT � During wakefulness and supine Baseline Device, No Suction Device @ 20 inches H 2 O 3
2/15/2014 Airway Percent Changes the Retropalatal Results - Retropalatal Airway Change with OPT Region for OPT Device Responders Percent Change BASELINE WITH OPT Baseline vs. OPT 0 * OPT 0 vs. OPT 20 † Baseline vs. OPT 20 * Measure Mean ± SD p‡ Mean ± SD p‡ Mean ± SD p‡ Average Retropalatal Airway Area 23.46 ± 51.81 0.1040 31.7 ± 37.98 0.0067 56.48 ± 65.63 0.0023 Per Slice (mm 2 ) Retropalatal Maximum A/P Distance -2.20 ± 15.13 0.5417 7.69 ± 8.34 0.0081 7.4 ± 17.23 0.0419 (mm) Retropalatal Maximum Cross- 8.30 ± 29.34 0.2958 66.84 ± 71.02 0.0001 78.31 ± 94.31 0.0002 Sectional Area (mm 2 ) Retropalatal Maximum Lateral 3.28 ± 16.58 0.5879 7.59 ± 12.22 0.0574 10.81 ± 16.39 0.0295 Distance (mm) Retropalatal Minimum A/P Distance 2.16 ± 41.47 0.4143 16.11 ± 29.64 0.0681 17.48 ± 63.51 0.3910 (mm) Retropalatal Minimum Cross- % Change Between Baseline and Device with 20 inches H 2 O 5.87 ± 38.60 0.9515 51.96 ± 74.78 0.0085 60.93 ± 88.64 0.0419 Sectional Area (mm 2 ) Minimum Airway Area: 116% Improvement (69 mm 2 Baseline | 149.3 mm 2 Device) Retropalatal Minimum Lateral -2.00 ± 15.08 0.6848 11.65 ± 16.53 0.0215 6.64 ± 10.89 0.0419 Maximum Airway Area: 20% Improvement (290.8 mm 2 Baseline | 347.9 mm 2 Device) Distance (mm) Yellow lines indicate minimum retropalatal airway (lateral dimension) at baseline *Change calculated with respect to baseline; †Change calculated with respect to OPT 0 ; ‡p- value from non-parametric signed rank test Airway Percent Changes the Retroglossal Airway Percent Changes the Retropalatal Region for OPT Device Responders and Non-Responders Region for OPT Device Responders Percent Change Baseline vs. OPT 0 * OPT 0 vs. OPT 20 † Baseline vs. OPT 20 * Percent Change Mean ± SD Mean ± SD Mean ± SD Baseline vs. OPT 0 * OPT 0 vs. OPT 20 † Baseline vs. OPT 20 * Measure p‡ p‡ p‡ Non- Non- Non- Responder Responder Responder Measure Responder Responder Responder Mean ± SD p‡ Mean ± SD p‡ Mean ± SD p‡ Average Airway Area -1.28 ± 56.48 ± -1.24 ± 23.46 ± 51.81 0.05 ± 0.83 0.2327 31.70 ± 37.98 0.0614 0.0078 Average Retroglossal Airway Area Per Per Slice (mm 2 ) 0.87 65.63 0.22 -20.08 ± 28.71 0.0203 -17.68 ± 23.91 0.0203 -36.53 ± 19.15 0.0001 Slice (mm 2 ) Maximum A/P -6.17 ± 7.40 ± -4.12 ± -2.20 ± 15.13 2.15 ± 2.42 0.4118 7.69 ± 8.34 0.0059 0.1013 Retroglossal Maximum A/P Distance Distance (mm) 5.62 17.23 6.88 -19.66 ± 13.85 0.0006 2.65 ± 14.95 0.4973 -18.23 ± 14.27 0.0009 (mm) Maximum Cross- -0.86 ± -1.07 ± 78.31 ± -1.91 ± 8.30 ± 29.34 0.3275 66.84 ± 71.02 0.0007 0.0078 Retroglossal Maximum Cross- Sectional Area (mm 2 ) 1.91 2.14 94.31 3.06 -9.48 ± 27.78 0.1937 -14.03 ± 29.70 0.1189 -25.83 ± 20.54 0.0004 Sectional Area (mm 2 ) Maximum Lateral -1.12 ± 10.81 ± 0.88 ± 3.28 ± 16.58 2.21 ± 5.29 0.8706 7.59 ± 12.22 0.2454 0.0464 Distance (mm ) Retroglossal Maximum Lateral 5.00 16.39 1.93 -0.35 ± 18.59 >0.999 -13.92 ± 21.07 0.0419 -13.36 ± 25.03 0.0353 Distance (mm) Minimum A/P -2.86 ± 17.48 ± -1.64 ± 2.16 ± 41.47 1.38 ± 5.77 0.4773 16.11 ± 29.64 0.0597 0.3275 Retroglossal Minimum A/P Distance Distance (mm) 3.04 63.51 2.96 -30.46 ± 16.17 0.0002 5.76 ± 24.07 0.6257 -26.76 ± 22.50 0.0031 (mm) Minimum Cross- -1.05 ± -3.53 ± 60.93 ± -4.61 ± 5.87 ± 38.60 0.7980 51.96 ± 74.78 0.0346 0.1575 Sectional Area (mm 2 ) Retroglossal Minimum Cross- 2.16 5.00 88.64 3.61 -30.93 ± 32.95 0.0052 -9.23 ± 32.70 0.3575 -44.85 ± 21.17 0.0001 Sectional Area (mm 2 ) Minimum Lateral -1.1 ± 6.64 ± 2.93 ± -2.00 ± 15.08 0.9563 11.65 ± 16.53 4.42 ± 6.80 0.3504 0.3817 Distance (mm) 10.15 10.89 7.85 Retroglossal Minimum Lateral -18.8 ± 30.77 0.0295 -6.19 ± 55.73 0.1189 -33.86 ± 24.46 0.0002 Distance (MM) *Change calculated with respect to baseline; †Change calculated with respect to OPT 0 ; ‡p-value *Change calculated with respect to baseline; †Change calculated with respect to OPT 0 ; ‡p-value from non-parametric Wilcoxon two-sample exact test, comparing changes in responders vs. non- from non-parametric signed rank test responders 4
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