Carlton, Australia

Zenko Clinical Pty Ltd.

Anxiety Disorders

Depression

Post-Traumatic Stress Disorders

Combat Disorders

Major Depressive Disorder

Wounds and Injuries

Senseye

condition

allSponsorName

Lindus Health

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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 a Machine Learning (ML) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the ML 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 Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected.
* Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually.
* Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually.

The total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.

REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool

Zenko Clinical Pty Ltd. | Carlton, Australia

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REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool

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