Condition: PTSD - Post Traumatic Stress Disorder · Sponsor: Senseye, Inc.
The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD. The Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a an Artificial Intelligence (AI) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the AI algorithm, then test it for accuracy. The main questions this study aims to answer are: 1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing? 2. How accurately does the Senseye DT predict PTSD severity? 3. How fast is the Senseye DT to use compared to structured clinical interviews? Participants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits: * Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating S…
This description comes directly from the study's public registry record.
Priscilla Nechrebecki · (833) 459-9365 · REVEALPTSD@lindushealth.com
Always discuss trial participation with your own doctor first.
| University of Colorado Anschutz Medical Campus | Aurora, Colorado, United States | Recruiting |
| Savannah VA Clinic | Savannah, Georgia, United States | Not Yet Recruiting |
| Velocity Clinical Research | Meridian, Idaho, United States | Recruiting |
| Lindus Health (Virtual Study Site) | Boston, Massachusetts, United States | Recruiting |
| Lowcountry Center for Veterans Research | Charleston, South Carolina, United States | Not Yet Recruiting |
| Zenko Clinical Pty Ltd (Virtual Study Site) | Carlton, Victoria, Australia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07280065