PI and Coordinator Webinar June 19, 2019

Overview Site Status and Enrollment Reminders NDMC: Randomization and Data Collection FusionHealth : Ordering supplies and Trial Completion Process Barnes Jewish: Enrollment Experience Discussion

Newsletter and Website We have a website! https://nihstrokenet.org/sleep-smart-trial/home. All study materials can be found here, including the recruitment video and Spanish materials. Our newsletter will be sent monthly, please be on the lookout for this for important study updates.

Site Readiness FusionHealth Agreements: 61 executed Clinical Trial Agreements: 80 executed CIRB approved sites: 46 sites Sites with all contracts executed and CIRB approval: 34 sites

Enrollments Sites open to enrollment: 11 Enrolled: 6 Subjects randomized: 3 Barnes Jewish Hospital, St. Louis MO Palmetto Prisma Health, Columbia SC Brooks Rehab Hospital, Jacksonville FL 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

Reminders-DOA Changes RT- Responsibilities E-G are within the normal scope of practice for a respiratory therapist. If other responsibilities are chosen, CITI training will be required. RT- Responsibility H is only needed if you think an RT will need to go into KOEO to configure the Nox T3 for Night 1. This can be done by a coordinator ahead of time. KOEO accounts-Anyone with responsibility H will need a KOEO account. Setting up an account requires a birthdate, please consider limiting the amount of people with H on your DOA. Otherwise gathering this information can take a lot of time. If you have submitted to the CIRB, please be aware any changes to the DOA will require an administrative amendment. This includes adding/removing team members, changing roles and responsibilities, etc. If possible, please try to consolidate changes.

Reminders- Randomizing Once a subject is randomized in WebDCU, please do not forget to login to KOEO to give the randomization assignment If randomized to Control group (No aCPAP)– Discard the masks, humidifier basin, and tubing from the run-in night device and provide the stroke symptom recognition handout to the subject If randomized to Intervention group (aCPAP) – Provide a new aCPAP device (set aside the run-in night device for the next opportunity) and provide the masks, humidifier basin, and tubing from the run-in night as extra supplies, and provide the stroke symptom recognition handout

Randomization-NDMC Submission of F102 Randomization generates the subject’s randomized treatment assignment. Please note that randomization cannot be undone. Prior to entering data in this CRF, the informed consent form must be signed by the subject, and the following CRFs must be submitted without any rule violations: F101 Eligibility F143 NIH Stroke Scale F291 ABCD2 F506 aCPAP Run-In Night

Data Submission Timelines CRF data must be submitted within 5 days of collection Exceptions: Adverse Events must be submitted within 5 days of knowledge of the event Death must be reported within 24 hours of knowledge of the event When a subject is found to be ineligible for randomization, please remember to move them to End of Study and complete the F126 End of Study CRF within 5 days

Who to Contact? Srikala Appana 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

Randomizing the first Sleep SMART subject Working as a team: The experience at Barnes Jewish Coordinator William Holt BSN, RN and PI Eric Landsness MD, PhD

Discussion What are some barriers your site is facing? How are sites managing and applying the Nox T3 during initial screening night?

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 sicklejc@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