PI and Coordinator Webinar July 31, 2019

Overview Site Status and Enrollment How to use the Sleep SMART Website Medicare ID NDMC: WebDCU FusionHealth: Process Reminders & how to interrogate a run in night CPAP Questions

Site Readiness FusionHealth Agreements: 70 Clinical Trial Agreements: 95 CIRB approved sites: 61 Sites with all contracts executed and CIRB approval: 47

Enrollments Sites open to enrollment: 24 Subjects enrolled: 52 Subjects randomized: 21 July randomizations: Brooks Rehabilitation Hospital, Jacksonville FL- Taisiya Matev and Parag Shah MD Cedars Sinai, Los Angeles CA- Vicki Manoukian and Oana Dumitrascu MD Harborview Medical, Seattle WA- Allison Kunze and Sandeep Khot MD Palmetto Health Richland, Columbia SC- Jane Lim, Phil Fleming, and Souvik Sen MD University of Utah, Salt Lake City UT- Theodore Rock and Jana Wold MD UCSD La Jolla and Hillcrest CA- Theresa Mcquaid, Karen Rapp, and Dawn Meyer PhD In order to schedule your site readiness call, the following need to be completed: Both FusionHealth Consignment and DUA executed CTA executed CIRB Approval All required training completed and uploaded in WebDCU- Trainings can be found here https://webdcu.musc.edu/campus/ KOEO access confirmed and equipment received by site Recommended dummy Nox T3 test completed

Website We have a website! https://nihstrokenet.org/sleep-smart-trial/home. The front page contains tabs to the majority of study materials and trainings you will need.

Website-Training Tab To get to the WebDCU campus website where all of the required trainings are: Click on Training-SleepSMART section.

Website-Research Team Tab

Website-Research Team Tab-Recruitment/Enrollment

Recruitment Challenges FAQ

Website-Research Team Tab-Nox T3 and Run In Night These are videos that will go through how to use the Nox T3 and CPAP and how to do a mask fitting for a subject. Please notice we have 6 MOP’s giving detailed step by step instructions for the Nox T3 and Run In Nights. The first 3 links are ResMed guides to CPAP. These can be provided to subjects &/or used by the study team. The other 3 links are videos that will show you how to fit the individual masks and how to clean them

Medicare ID When “add new subject” in WebDCU, the subject enrollment form opens automatically. On the form, is where the Medicare ID question is. If a subject does have one, the green arrow will link to where you need to fill it out. This is in Qualtrics

Outcome Packet Upload Don’t move the subject directly to End of Study! Upload in F504 Primary Outcome Report Packet Contents PHI If your subject has an AE that will need adjudication, then remember that the AE packet does not need to be uploaded until the subject reaches End of Study. Just because the subject had an AE doesn’t mean that they need to be moved directly to End of Study! The subject is still eligible to be in the trial, even if they have multiple AEs that need adjudication. Instead, let the subject naturally be moved to end of study. You will receive an email once you submit an AE that will require adjudication. This email is more of a reminder to start compiling the packet so that it is ready when the subject reaches End of Study, not an indication that you need to move them directly to End of Study and upload the packet. The packet will be uploaded in F504 Primary Outcome Report as either one PDF file or as a zip file. The packet is something that you compile, not a form that we give you to fill out. What should all be included in the packet can be found in [project documents] called ‘Sleep SMART Required Documentation for Event Adjudication Packet” This document should include no PHI anywhere in the document.

F291 ABCD2 If the subject does not have a TIA, then don’t fill out the form as Data Collected = [No] and put in general comments what type of stroke the subject had. This is not the correct way to fill out this form! Instead, please put Data collected = [Yes] and Q01 should be [No]. Many of you should have already received a DCR about this. Please update F291, submit the CRF, and respond to the DCR.

Report Your Adverse Events! Before Randomization: SAEs and select non-serious AEs related to the Nox T3 sleep apnea test or the aCPAP run-in night. After Randomization All SAEs and select non-serious AEs This includes… Ischemic stroke, hemorrhagic stroke, acute coronary syndrome Pneumonia, pneumothorax, car crash or other physical injury related to sleepiness, or skin infection on face. Please remember to report your Adverse Events! What all is reportable?

Subject Visits Order If the subject is discharged before Randomization, but you are still planning to randomize the subject… Post the Randomization visit first, then post the hospital discharge visit with the same date as the randomization visit. You will not be able to post the hospital discharge visit without first posting the randomization visit. If you have a subject who was discharged before you randomized them, but you are still planning on randomizing the subjects. Then please add the randomization visit and then add the hospital discharge visit with the same date as the randomization visit. Then in Q01, you can put the correct discharge date. You will not be able to add the hospital discharge visit without the subject being randomized first.

Who to Contact? Srikala Appana at NDMC Jocelyn Anderson at NDMC appana@musc.edu When to contact: If you have WebDCU-related DOA/regulatory database questions, Informed Consent Remote Monitoring questions, or Site Monitoring questions Faria Khattak at NDMC khattak@musc.edu When to contact: Any other WebDCU-related or CRF-related questions Jocelyn Anderson at NDMC anderjoc@musc.edu When to contact: Any other WebDCU-related or CRF-related questions

Sleep SMART Process Reminders

Reminder on how to Create New Patient Enter the following fields then click Save on top right.

Potential Next Tasks after Scoring

Excluded - Print Report Reminder: Please complete the Excluded - Print Report Task in KOEO This task appears if subject is NOT ELIGIBLE for Run-In Night. Process must be closed out

Excluded - Print SleepSMART Report

Interrogating aCPAP after Run-In Night

ResMed AirSense10 AutoSet Sleep Report Toggle to Sleep Report Push the round dial Usage hours Events per hour Mask Seal Humidifier status come to view Start scrolling with the dial

ResMed AirSense10 AutoSet Sleep Report - 2nd screen Scroll down to Period Period MUST be set to 1 day If any other period is set, please change to 1 day Toggle to 1 day (highlight) and push the center button on the dial

ResMed AirSense10 AutoSet Sleep Report - 3rd screen The full Sleep Report has 10 lines of data The display screen accommodates 7 lines of data You need to scroll to view all the information Period 1 day Days Used Days 4hrs+ Avg. Usage Used Hrs Pressure Leak AHI Total AI Central AI

Form 506: aCPAP Run-In Night Date of the Run-In Night From the aCPAP: Used Hrs From the aCPAP: Pressure From the aCPAP: Leak From the aCPAP: AHI From the aCPAP: AI

Questions?

Contacts Sleep SMART enrollment help Email Helpline 9am to 8pm ET: sleepsmart@umich.edu WebDCU Emergency Randomization Hotline: 1-866-450-2016 Prime Site Project Manager Kayla Novitski, MPH, CCRP kcgossel@med.umich.edu or 734-615-2006 NCC Project Manager Joelle Sickler, MSN, RN, CCRC, CCRA sicklejb@ucmail.uc.edu or 513-558-3942 Regulatory help Jennifer Golan, MS golanjl@ucmail.uc.edu or 513-558-3976 Emily Stinson, MS stinsoey@ucmail.uc.edu or 513-558-3979 WebDCU help Jocelyn Anderson, MPH anderjoc@musc.edu or 843-876-1167 Faria Khattak, MPH khattak@musc.edu or 984-221-0266

Contacts FusionHealth contact information For study staff questions about Nox T3, KOEO, aCPAP, or masks: 1-888-505-0280 extension 4006 Sleep SMART Care Team number for subjects/caregivers in the aCPAP arm: 470-655-6688 Contracts help Fusion Contracts (DUA and Consignment): Greg Fletcher gfletcher@fusionhealth.com or StrokeNet contracts (CTAs): Diane Sparks RN, BS sparksdn@ucmail.uc.edu and Wren Hanson hansonwm@ucmail.uc.edu Principal Investigators Devin L. Brown MD, MS devinb@med.umich.edu Ronald D. Chervin MD, MS chervin@med.umich.edu