Oral Pressure Therapy for OSA Oral Pressure Therapy for OSA - Disclosures Richard J. Schwab, M.D. Professor of Medicine Division of Sleep Medicine Pulmonary, Allergy and Critical Care Division University of Pennsylvania Medical Center Philadelphia, Pennsylvania NIH grants - RO1/PPG (Obesity and OSA) Consultant: Apnicure - Winx TM device Foramis Medical Group Winx TM (OPT) Device A novel oral pressure therapy (OPT) system (Winx TM, ApniCure, Inc.) provides negative pressure to the oral cavity Introduction OPT has been shown to effectively treat sleep apnea in about 40% of patients (Colrain IM et al. Sleep Medicine 14; 830 837, 2013) Console Mouth Piece 1
AHI and ODI: Cohort (n=26) AHI by Severity: Analysis Cohort (n=63) Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea Schwab et al, submitted to sleep (conditionally accepted) Winx TM Device Study Objectives and Design Objective of the study was to explore the mechanism of action of the OPT (oral pressure therapy) device Case series study of 15 responders (13 men, 2 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
Hypotheses With the application of oral pressure therapy (OPT): Mean, minimum and maximum airway area in the retropalatal region would increase Retropalatal anterior-posterior and lateral airway dimensions would increase Retroglossal airway dimensions would not change 3-dimensional centroid of the soft palate and anterior segment of the tongue would move anteriorly and superiorly Demographic Information for OPT Subjects Characteristic s (n=15) s (n=4) Age, mean ± SD 58.1 ± 7.7 48.0 ± 8.2 0.1133 BMI, mean ± SD 30.9 ± 4.0 32.9 ± 3.6 0.2621 Male, N (%) 13 (87%) 3 (75%) 0.5304 AHI at Baseline, mean ± SD 38.5 ± 23.3 24.3 ± 19.4 0.2208 AHI on Device, mean ± SD 6.7 ± 5.0 27.9 ± 24.0 0.0093 AHI Change, mean ± SD -31.9 ± 20.2 3.6 ± 14.9 0.0059 *p-value from Fisher s exact test (for categorical variable) or Wilcoxon two-sample exact test (for continuous variables) comparing responders and non-responders p* Methods: OPT Application 3D Image Analysis Magnetic Resonance Imaging (1.5T) During wakefulness and supine Baseline Device, No Suction Device @ 20 inches H 2 O BASELINE WITH OPT 3
Results - Retropalatal Airway Change with OPT BASELINE WITH OPT % Change Between Baseline and Device with 20 inches H 2 O Minimum Airway Area: 116% Improvement (69 mm 2 Baseline 149.3 mm 2 Device) Maximum Airway Area: 20% Improvement (290.8 mm 2 Baseline 347.9 mm 2 Device) Yellow lines indicate minimum retropalatal airway (lateral dimension) at baseline Airway Percent Changes the Retropalatal Region for OPT Device s Average Retropalatal Airway Area Per Slice (mm 2 ) Retropalatal Maximum A/P Distance Retropalatal Maximum Cross- Retropalatal Maximum Lateral Retropalatal Minimum A/P Distance Retropalatal Minimum Cross- Retropalatal Minimum Lateral Percent Change 23.46 ± 51.81 0.1040 31.7 ± 37.98 0.0067 56.48 ± 65.63 0.0023-2.20 ± 15.13 0.5417 7.69 ± 8.34 0.0081 7.4 ± 17.23 0.0419 8.30 ± 29.34 0.2958 66.84 ± 71.02 0.0001 78.31 ± 94.31 0.0002 3.28 ± 16.58 0.5879 7.59 ± 12.22 0.0574 10.81 ± 16.39 0.0295 2.16 ± 41.47 0.4143 16.11 ± 29.64 0.0681 17.48 ± 63.51 0.3910 5.87 ± 38.60 0.9515 51.96 ± 74.78 0.0085 60.93 ± 88.64 0.0419-2.00 ± 15.08 0.6848 11.65 ± 16.53 0.0215 6.64 ± 10.89 0.0419 *Change calculated with respect to baseline; Change calculated with respect to OPT 0 ; pvalue from non-parametric signed rank test Airway Percent Changes the Retropalatal Region for OPT Device s and s Average Airway Area Per Slice (mm 2 ) Maximum A/P Maximum Cross- Percent Change 23.46 ± 51.81 0.05 ± 0.83 0.2327 31.70 ± 37.98-2.20 ± 15.13 2.15 ± 2.42 0.4118 7.69 ± 8.34 8.30 ± 29.34-0.86 ± 1.91 0.3275 66.84 ± 71.02 Maximum Lateral Distance (mm ) 3.28 ± 16.58 2.21 ± 5.29 0.8706 7.59 ± 12.22 Minimum A/P Minimum Cross- Minimum Lateral 2.16 ± 41.47 1.38 ± 5.77 0.4773 16.11 ± 29.64 5.87 ± 38.60-2.00 ± 15.08-1.05 ± 2.16-1.1 ± 10.15 0.7980 51.96 ± 74.78-1.28 ± 0.87-6.17 ± 5.62-1.07 ± 2.14-1.12 ± 5.00-2.86 ± 3.04-3.53 ± 5.00 0.0614 0.0059 0.0007 0.2454 0.0597 0.0346 0.9563 11.65 ± 16.53 4.42 ± 6.80 0.3504 56.48 ± 65.63 7.40 ± 17.23 78.31 ± 94.31 10.81 ± 16.39 17.48 ± 63.51 60.93 ± 88.64 6.64 ± 10.89 *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. nonresponders -1.24 ± 0.22-4.12 ± 6.88-1.91 ± 3.06 0.88 ± 1.93-1.64 ± 2.96-4.61 ± 3.61 2.93 ± 7.85 0.0078 0.1013 0.0078 0.0464 0.3275 0.1575 0.3817 Airway Percent Changes the Retroglossal Region for OPT Device s Average Retroglossal Airway Area Per Slice (mm 2 ) Retroglossal Maximum A/P Distance Retroglossal Maximum Cross- Retroglossal Maximum Lateral Retroglossal Minimum A/P Distance Retroglossal Minimum Cross- Retroglossal Minimum Lateral Distance (MM) Percent Change -20.08 ± 28.71 0.0203-17.68 ± 23.91 0.0203-36.53 ± 19.15 0.0001-19.66 ± 13.85 0.0006 2.65 ± 14.95 0.4973-18.23 ± 14.27 0.0009-9.48 ± 27.78 0.1937-14.03 ± 29.70 0.1189-25.83 ± 20.54 0.0004-0.35 ± 18.59 >0.999-13.92 ± 21.07 0.0419-13.36 ± 25.03 0.0353-30.46 ± 16.17 0.0002 5.76 ± 24.07 0.6257-26.76 ± 22.50 0.0031-30.93 ± 32.95 0.0052-9.23 ± 32.70 0.3575-44.85 ± 21.17 0.0001-18.8 ± 30.77 0.0295-6.19 ± 55.73 0.1189-33.86 ± 24.46 0.0002 *Change calculated with respect to baseline; Change calculated with respect to OPT 0 ; p-value from non-parametric signed rank test 4
Airway Percent Changes the Retroglossal Region for OPT Device s and s Average Airway Area Per Slice (mm 2 ) Maximum A/P Maximum Cross- Maximum Lateral Minimum A/P -20.08 ± 28.71-19.66 ± 13.85-9.48 ± 27.78-0.35 ± 18.59-30.46 ± 16.17 Percent Change Mean±SD Mean±SD Mean±SD -35.63 ± 6.57 0.5739-5.81 ± 0.84 0.1013-4.42 ± 10.28 0.7209-0.32 ± 3.89 0.9588-6.58 ± 3.99 0.0078-17.68 ± 23.91 2.65 ± 14.95-14.03 ± 29.70-13.92 ± 21.07 5.76 ± 24.07 19.24 ± 71.44 0.5052 7.63 ± 1.12 0.7849 3.54 ± 11.94 0.1575-2.98 ± 2.29 0.1922 9.73 ± 8.78 0.7980-36.53 ± 19.15-18.23 ± 14.27-25.83 ± 20.54-13.35 ± 25.03-26.76 ± 22.50-26.68 ± 33.91 0.5965 1.38 ± 1.39 0.0118-1.95 ± 2.32 0.0196-3.31 ± 4.07 0.3571 2.33 ± 6.29 0.0093 Results - Soft Tissue Effect with OPT Anterior Tongue Baseline Treatment Oral pressure therapy (OPT) treatment moved the 3-dimensional centroid of the soft palate anteriorly 12.9 ± 4.1 mm and superiorly 10.0 ± 3.6 mm Oral pressure therapy (OPT) treatment moved the centroid of the anterior segment of the tongue forward, towards the teeth, 7.8 ± 3.3 mm Minimum Cross- -30.93 ± 32.95-6.09 ± 9.08 0.0464-9.23 ± 32.70-5.21 ± 11.7 0.7980-44.85 ± 21.17-11.61 ± 7.08 0.0062 Minimum Lateral -18.80 ± 30.77-1.71 ± 6.95 0.2327-6.19 ± 55.73-1.58 ± 4.42 0.0791-33.86 ± 24.46-3.43 ± 4.92 0.0485 *Change calculated with respect to baseline; Change calculated with respect to OPT 0 ; p-value from nonparametric Wilcoxon two-sample exact test, comparing changes in responders vs. non-responders Anterior Tongue Changes in the 3 Dimensional Centroid of the Anterior Quadrant of the Tongue and 3 Dimensional Centroid of the for OPT Device s Difference Changes in the 3 Dimensional Centroid of the Anterior Quadrant of the Tongue and 3 Dimensional Centroid of the for OPT Device s and s Difference Section: Anterior -2.42 ± 3.27 0.0134-4.87 ± 3.74 0.0007-6.52 ± 3.90 0.0002 Section: Anterior -2.42 ± 3.27-0.10 ± 3.18 0.7034-4.87 ± 3.74-0.89 ± 3.24 0.1017-6.52 ± 3.90-0.99 ± 1.98 0.0078 Section: Superior -4.03 ± 3.25 0.0012 4.62 ± 2.42 0.0002 0.58 ± 2.18 0.4631 Section: Superior -4.03 ± 3.25-0.19 ± 1.46 0.0227 4.62 ± 2.42 1.15 ± 1.48 0.0445 0.58 ± 2.18 0.96 ± 1.55 0.6451 : Anterior -3.55 ± 2.54 0.0002-8.54 ± 3.38 0.0002-10.96 ± 5.42 0.0002 : Anterior -3.55 ± 2.54 0.30 ± 5.08 0.1017-8.54 ± 3.38-7.35 ± 7.31 0.2958-10.96 ± 5.42-7.04 ± 2.98 0.0614 : Superior Displacement 8.95 ± 1.59 0.0002 7.23 ± 7.04 0.0017 15.31 ± 7.37 0.0001 : Superior 8.95 ± 1.59 2.17 ± 4.98 0.0319 7.23 ± 7.04 2.61 ± 2.23 0.2958 15.31 ± 7.37 4.79 ± 6.45 0.0248 *Change calculated with respect to baseline; Change calculated with respect to OPT 0 ; p-value from non-parametric signed rank test *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-responders 5
ment and Results Oral pressure therapy significantly increased the size of the retropalatal airway in both the lateral and anterior-posterior dimensions by moving the soft palate anteriorly and superiorly and the anterior-superior segment of the tongue forward, towards the teeth In the retropalatal region there were significant increases in the mean, maximum and minimum cross-sectional areas with the OPT device However, in the retroglossal region airway caliber decreased with the OPT device Conclusions Oral pressure therapy (OPT), a novel treatment for sleep apnea, increases the size of the retropalatal airway by moving the soft palate anteriorly and superiorly and the anterior segment of the tongue forward, towards the teeth OPT increases airway caliber in both the anteriorposterior and lateral dimensions This treatment did not increase the size of the retroglossal airway Our data suggest that patients manifesting an enlarged soft palate or exhibiting retropalatal airway collapse would be ideal candidates for OPT therapy Next Generation Winx+ (adds a tongue retaining device Winx+ WINX 6
Feasibility Study of Winx+ Mouthpiece Subjects: 25 OSA patients naïve to Winx with AHI > 15 events/hour Protocol: Baseline full night PSG off therapy Full night PSG on Winx+ device followed by 4 nights use at home. Results of Feasibility Study #2: 25 Subjects to Date AHI Baseline Winx+ 37.8 19.3 16/25 (64%) had a > 50 reduction in AHI and final AHI < 20 16/25 (64%) had a > 50 reduction in AHI and final AHI < 15 13/25 (52%) had a > 50 reduction in AHI and final AHI < 10 Baseline, Winx, and Winx+ from the Sagittal View Baseline, Winx, and Winx+ from the Axial View (Retropalatal Airway) Baseline Winx Winx+ In this subject, the Winx device creates little to no change in the retropalatal region of the airway, while Winx+ creates more space behind the the soft palate increasing airway volume in the retropalatal region. The yellow arrows represent the Winx suction mechanism; the red arrow represents the tongue protrusion allowed for with Winx+. Baseline airway CSA = Winx airway CSA = Winx+ airway CSA = 95.2 mm 2 105.3 mm 2 231.9 mm 2 In this subject, the Winx device creates little to no change in the retropalatal region of the airway, while Winx+ creates more space behind the the soft palate increasing airway caliber in the retropalatal region. CSA = cross-sectional area 7
Baseline Oral Pressure Therapy for OSA Device Device Winx Winx+ Thank you for your attention! Any Questions? rschwab@mail.med.upenn.edu 8