Clinical Trials in OSA

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1 24th ANNUAL ADVANCES IN SLEEP APNEA AND SNORING February 16-17, 2018 Grand Hyatt on Union Square San Francisco, California Clinical Trials in OSA Samuel T. Kuna, MD Department of Medicine Center for Sleep and Circadian Neurobiology University of Pennsylvania and Sleep Medicine Section Crpl Michael J. Crescenz VAMC Philadelphia, PA What is the best model of care and who should deliver it? Initial Evaluation Initial Evaluation In-lab PSG Home sleep study Diagnostic PSG Titration PSG AutoCPAP AutoCPAP PAP Clinic FU Clinic FU 1

2 Veterans Sleep Apnea Treatment Trial Sleep Clinic Evaluation In-lab (split night) Home sleep polysomnogram study AHI < 15 AHI < 15 Clinic F/U In-lab PSG CPAP titration Home APAP titration In-lab PSG Set home CPAP to PSG CPAP titration Set home CPAP to APAP titration CPAP adherence Functional Outcomes Medical Care Cost Kuna et al. AJRCCM 183: , 2011 Mean (SD) of FOSQ total score by group at baseline and month 3 in subjects initiated on CPAP Kuna et al. AJRCCM 183: ,

3 Change in FOSQ score from baseline to month 3 between groups Endpoint FOSQ total score Hypothesis: Ho: H- L -1.0 vs. Ha: H- L -1.0 Home mean change 1 (n=105) In-lab mean change 1 (n=96) Adjusted difference in mean changes (SE) P-value 2 Lower bound of 90% CI for difference in mean changes (0.33) Adjusted mean changes and differences in mean changes were estimated as sitetotal sample-size weighted values controlling for group differences in mean pre values 2 P-value from Type II sum of squares estimated by way of ANCOVA. To produce site weighted comparisons the ANCOVA model included main effects for type of study (home vs in-lab), site, as well as the pre- baseline value of the outcome measure. Kuna et al. AJRCCM 183: , Kuna et al. AJRCCM 2011; 183: Mean CPAP adherence from baseline to month 3 between groups Hypothesis: Ho: H- L vs. Ha: H- L Endpoint Mean CPAP (hr/day) Home mean 1 (n=113) In-Lab mean 1 (n=110) Adjusted difference in mean (SE) 1 P-value 2 Lower bound of 90% CI for difference in means (0.32) Adjusted means and differences in means were estimated as site-total-samplesize weighted values controlling. 2 P-value from Type II sum of squares estimated by way of analysis of covariance. To produce site weighted comparisons the ANCOVA model included main effects for type of study (home vs in-lab) and site. Kuna et al. AJRCCM 183: , Kuna et al. AJRCCM 2011; 183:

4 Change in secondary endpoints within arm from baseline to month 3 in subjects initiated on CPAP Home testing In-Lab testing Variable N Mean P-value N Mean P-value ESS score ± 5.2 < ± 4.4 < PVT lapses ± ± SF-12 (phys) ± ± SF-12 (mental) ± ± CES-D ± ± Kuna et al. AJRCCM 183: , Kuna et al. AJRCCM 2011; 183: Endpoint Change from baseline to month 3 in subjects initiated on CPAP Home mean change 1 In-Lab mean change 1 Adjusted difference in mean changes ± SE P-value 2 ESS score ± PVT (transformed lapses) ± SF-12 physical score ± SF-12 mental health score ± CES-D ± Adjusted mean changes and differences in mean changes were estimated as site-total-sample-size weighted values controlling for group differences in mean pre baseline values. 2 P-value from Type II sum of squares estimated by way of analysis of covariance. To produce site weighted comparisons the ANCOVA model included main effects for type of study (home versus in-lab), site, as well as the pre baseline value of the outcome measure. Kuna et al. AJRCCM 183: , Kuna et al. AJRCCM 2011; 183:

5 Patient-centered outcome research testing ambulatory management of OSA Mulgrew et al. Diagnosis and initial management of OSA without polysomnography: A randomized validation study. Ann Intern Med. 2007;146: Berry et al. Portable monitoring and autotitration versus polysomnography for the diagnosis and of sleep apnea. Sleep. 2008;31: Rosen et al. A multi-site randomized trial of portable sleep studies and PAP autotitration versus laboratory-based PSG for the diagnosis and of OSA: The HomePAP study. Sleep 2012; 35: Antic et al. A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea. Amer J Respir Crit Care Med. 2009;179: Laboratory PSG or limited-channel sleep studies for OSA Baseline assessment Diagnostic PSG (n = 406) Level 1 (n = 135) Level 2 (n = 136) Level 3 (n = 135) 4-mo follow-up (n = 98) 4-mo follow-up (n = 103) 4-mo follow-up (n = 109) Chai-Coetzer et al. Ann Intern Med 2017; 166:

6 Laboratory PSG or limited-channel sleep studies for OSA Chai-Coetzer et al. Ann Intern Med 2017; 166: Alternate methods of titrating CPAP 360 patients with suspected OSA Diagnostic PSG AHI 30; ESS 12 Home autoadjust (n = 106) Manual in-lab titration (n = 107) Predicted formula (n = 115) To eliminate hypopneas, snoring and flow limitation One night at home with AutoSet-T. Repeat x2 prn BMI, AHI, and Neck Circumference with domestic adjustment Outcome measures following 12 weeks CPAP : In-lab PSG (AHI), ESS, FOSQ, SF-36, EuroQOL Masa et al. AJRCCM 2004; 170:

7 Auto vs fixed CPAP for OSA: a multicentre, randomised equivalence trial Apnea-hypopnea index CPAP use Bloch KE et al. Thorax 2018;73: Auto vs fixed CPAP for OSA: a multicentre, randomised equivalence trial Epworth Sleepiness Scale Functional Outcome of Sleep Bloch KE et al. Thorax 2018;73:

8 Does giving patients access to their PAP data improve use? 195 patients with newly diagnosed OSA (AHI 15) Randomized (n=139) Usual care (n=53) Web-based access + $$ incentive (n=40) Web-based access (n=46) 3 month Visit (n=52) 3 month Visit (n=39) 3 month Visit (n=45) Kuna ST et al. Sleep 2015; 38: Mean (SD) hours of use per week over 3 3 months Average hours of use per week Average use per week (hr) Web only Web + $$ Usual care Weeks Kuna ST et al. Sleep 2015; 38:

9 The emerging paradigm: HSAT, autocpap with remote monitoring and videoconferencing In-lab PSG Initial In-person Home sleep study Phone or video teleconference Store and forward Diagnostic PSG AutoCPAP Split PSG CPAP AutoCPAP Clinic FU Store and forward of wireless data Phone or video teleconference Long term management Phone or video teleconference Primary care practice vs sleep center management of OSA 155 patients with OSA recruited from primary care practices High diagnostic likelihood of moderate to severe OSA based on a screening questionnaire, ODI-3% 16 events/hr, ESS 8 Randomized to management at the primary care practice or the sleep center Community-based nurse and PCP physician participated in a 6-hour education program on OSA and its management Community-based nurses received 5 days of in-service training with specialist nurses at the sleep center Chai-Coetzer et al. JAMA. 2013;309(10):

10 Primary care practice vs sleep center management of OSA Change in Epworth score at 6 months Adjusted difference in mean change 0.13 Lower bound of 1-Sided 95% CI -1.5 Chai-Coetzer et al. JAMA. 2013;309(10): Primary care practice vs sleep center management of OSA No difference in secondary outcomes at 6 months Primary Care Specialist Sleep Center Chai-Coetzer et al. JAMA. 2013;309(10):

11 Conclusions Functional outcomes and CPAP use with ambulatory management of patients with OSA is not clinically inferior to that with in-laboratory management Management and outcomes are improved using a type 3 rather than a type 4 portable monitor Application of telehealth, HST, and autocpap with wireless monitoring is enabling patient access to care without traveling to a sleep center Emerging evidence that non-md healthcare providers can manage patients with OSA 11

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