Featured Research Program
Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken): A Randomized Controlled Trial
Nightmare disorder consists of frequent nightmares and sleep disturbances and is highly prevalent among individuals with insomnia and psychiatric conditions. Clinically unattended nightmare disorder can lead to serious comorbid conditions and exacerbate underlying psychological dysfunction. Treating nightmare disorder is an integral part of treating sleep disturbances to improve quality of life, especially in vulnerable populations such as those that suffer post-traumatic stress disorder (PTSD) and other psychiatric illnesses. Currently, nightmare disorder is under-recognized and under-treated, stemming from the lack of understanding of disease mechanisms as well as limited research on effective treatments.
Dr. Ambrose Chiang, Dr. Kamal Gandotra, and their colleagues will be conducting a randomized clinical trial of NightWare, an FDA-cleared novel digital therapeutics for nightmare disorders and PTSD-associated nightmares. NightWare is a proprietary software application on a wrist-worn device used while sleeping. NightWare continuously monitors heart rate and movement to determine when nightmares are likely to be occurring and then vibrates to interrupt the nightmare without disturbing their sleep. Preliminary data of this device demonstrates improved overall sleep quality, sleep latency, and sleep disturbances. In the first 30 days, the participants will be randomized to either active or sham treatment. Study participation will last 90 days in total.
Please contact Dr. Ambrose Chiang, ambrose.chiang@va.gov, if you’d like more information on the NightWare study.
Research Forums
Research forums will be held monthly at the VA in Room K119. Our spring schedule for forums is listed below. We encourage you to attend in person if you can. If you are unavailable to attend in person, you will have the option to view the presentation via Teams.
Tuesday, June 20, 2023 @1:00PM
Flagging Process in CPRS
presented by Larry Foote, Health System Specialist
Microsoft Teams meeting; Join on your computer, mobile app or room device
Meeting ID: 216 390 136 01 Passcode: vvDwK7
Or call in (audio only)
+1 872-701-0185,,643 542 369#
Click here to join the meeting
Tuesday, July 18 @ 1:00pm
Privacy Q & A: presented by Joe Picklo and Tomica Jefferson, Privacy Specialists
Tuesday, August 15 @ 1:00pm
Non-Veterans in VA Research: presented by Christina Bennett, Health System Specialist
Tuesday, September 19 @ 1:00pm
Modifications and Closures with IRB: presented by, Jacqueline Charles, IRB Administrator & Joy Volpi IRB Coordinator
Updated SOP's
https://www.clevelandvaresearch.org/research-sops
HSP-004 CPRS Medical Records for Non-Veterans Research Subjects and Veterans not
Currently Enrolled in the VA Healthcare System (updated 6/1/2023)
HSP-016 Research Clinics (updated 6/1/2023)
For questions, contact Candice Toney, Education/Policy Specialist candice.toney@va.gov
VA Directive 1058.01, Research Compliance Reporting Requirements
This month we would like to highlight VA Directive 1058.01, Research Compliance Reporting Requirements. This directive outlines requirements, including time lines, for reporting research noncompliance and other select research related events such as Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others UPIRTSOs. The Directive provides definitions for Continuing Noncompliance, Serious Noncompliance and UPIRTSOs. We recommend you take a moment to review the Directive with your team. The Directive along with decision charts for reporting can be found on the ORO website ORO Publications and Guidance - Office of Research Oversight (va.gov).
Research Compliance Office
Research Compliance Officer, Jennifer Zindle, will begin her maternity leave on June 12th. In her absence, Brian Williams (VISN RCO) will be filling in for her.
If you have any questions or concerns related to research compliance, please don't hesitate to email Brian at brian.williams5@va.gov. We wish Jennifer a safe and healthy delivery.
Office Hours with (Research Compliance & Research Service)
On June 9th, we will have the IRB team (Jacqui & Joy) answering your IRB questions. Please gather your questions and join us via teams from 12:30pm-1:00pm.
If you are unable to attend office hours, you can view the recording in the chat at a later date.
Office hours is an opportunity for you to get answers to questions that you may have about conducting research. If you have topics you would like to see presented in future office hours, please reach out to candice.toney@va.gov
Please use the link below to join us Friday, June 9th at 12:30pm
Join on your computer, mobile app or room device
Click here to join the meeting
Meeting ID: 272 015 014 191 Passcode: kDx3KT
Study Initiation Visits
What is a Study Initiation Visit?
The study initiation visit encompasses a review of regulatory requirements as they apply to your specific study, good clinical practice guidelines, the informed consent and HIPAA documents as well as a review of how to maintain study records (regulatory binder and subject files).
The Research Compliance Office is required to perform a triennial regulatory audit of studies (human subjects' research, animal protocols, and basic science studies) and informed consent and HIPAA audits if applicable. The intent of a study initiation visit is to help the researcher avoid the most common audit findings before they occur.
Did you know that you can schedule a Study Initiation Visit with the Research Service?
The study initiation visit is available to all research staff. If you are new to research or need a refresher, you can schedule a study initiation visit today.
For scheduling or questions contact Candice Toney at Candice.Toney@va.gov or 216-791-3800 x66785
Upcoming VA Research Funding Deadlines
VA RR&D and HSR&D funding applications are submitted in June and December. For June 2023, the last day to submit is June 8.
All submissions must be reviewed and approved by the R&D Committee prior to submitting. if you are planning to submit a grant application this upcoming Winter cycle. Please contact Christine Hendricks (Christine.hendricks@va.gov).
Office of Research & Development
A full list of upcoming webinars can be found at: Office of Research Protections, Policy, and Education Webinars (va.gov)
6/13/2023 VA Central IRB: Continuing Review Process and Form Changes
Archived webinars can be found at: ORPP&E Webinar Archive (va.gov)
Stay Connected
VA Northeast Ohio Healthcare System
Cleveland Research Website
Office of Research & Development
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