1. PI and Coordinator Webinar
July 31, 2019

2. 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

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

5. 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
KOEO access confirmed and equipment received by site
Recommended dummy Nox T3 test completed

6. Website
We have a website! The front page contains tabs to the majority of study materials and trainings you will need.

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

8. Website-Research Team Tab

9. Website-Research Team Tab-Recruitment/Enrollment

10. Recruitment Challenges
FAQ

11. 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

12. 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

13. 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 once you submit an AE that will require adjudication. This 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.

14. 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.

15. 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?

16. 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.

17. Who to Contact? Srikala Appana at NDMC Jocelyn Anderson 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

18. Sleep SMART Process Reminders

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

20. Potential Next Tasks after Scoring

21. 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

22. Excluded - Print SleepSMART Report

23. Interrogating aCPAP after Run-In Night

24. 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

25. 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

26. 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

27. 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

28. Questions?

29. 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

30. 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