1. PI and Coordinator Webinar
June 19, 2019

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

4. Newsletter and Website
We have a website! 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.

5. 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

6. 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
KOEO access confirmed and equipment received by site
Recommended dummy Nox T3 test completed

7. 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.

8. 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

9. 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

10. 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

11. Who to Contact?
Srikala Appana at NDMC 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 When to contact: Any other WebDCU-related or CRF-related questions Jocelyn Anderson at NDMC When to contact: Any other WebDCU-related or CRF-related questions

29. 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

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

31. Contacts
Sleep SMART enrollment help Helpline 9am to 8pm ET: WebDCU Emergency Randomization Hotline: Prime Site Project Manager Kayla Novitski, MPH, CCRP or NCC Project Manager Joelle Sickler, MSN, RN, CCRC, CCRA or Regulatory help Jennifer Golan, MS or Emily Stinson, MS or WebDCU help Jocelyn Anderson, MPH or Faria Khattak, MPH or

32. Contacts
FusionHealth contact information For study staff questions about Nox T3, KOEO, aCPAP, or masks: extension 4006 Sleep SMART Care Team number for subjects/caregivers in the aCPAP arm: Contracts help Fusion Contracts (DUA and Consignment): Greg Fletcher or StrokeNet contracts (CTAs): Diane Sparks RN, BS and Wren Hanson Principal Investigators Devin L. Brown MD, MS Ronald D. Chervin MD, MS