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NCT07280065 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of PTSD - Post Traumatic Stress Disorder, sponsored by Senseye.

Recruiting
Registry status
Phase 3
Development phase
1,900
Enrollment target
6
Study locations

NCT07280065 is a Phase 3 study of PTSD - Post Traumatic Stress Disorder that is actively recruiting participants, run by Senseye. The registered enrollment target is 1,900 participants, above the 144-participant average among 14 other PTSD - Post Traumatic Stress Disorder trials with a reported enrollment target (1219% higher). The trial reports 6 study locations across 6 states.

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The verdict

NCT07280065, a Phase 3 study of PTSD - Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Senseye.

RECRUITING
Registry status
Phase 3
Development phase
1,900 participants
Enrollment target
6
Study locations

Study Summary

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 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 n

Interventions

  • DEVICE Senseye Diagnostic Tool (DT)
  • BEHAVIORAL Clinician Administered PTSD Scale for DSM-5, Revised Version

Study Locations (6)

Colorado

  • University of Colorado Anschutz Medical Campus - Aurora

Georgia

  • Savannah VA Clinic - Savannah

Idaho

  • Velocity Clinical Research - Meridian

Massachusetts

  • Lindus Health (Virtual Study Site) - Boston

South Carolina

  • Lowcountry Center for Veterans Research - Charleston

Victoria

  • Zenko Clinical Pty Ltd (Virtual Study Site) - Carlton

Trial Details

FieldValue
Enrollment Target 1,900 participants
Start Date 2026-02
Est. Completion 2026-10
Phase Phase 3

Sponsor

Senseye

3 total trials

What the Registry Record Tells You About NCT07280065

The ClinicalTrials.gov registry entry for NCT07280065 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,900 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 144-participant average among 14 other PTSD - Post Traumatic Stress Disorder trials with a reported enrollment target (1219% higher). The listed sponsor is Senseye, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with PTSD - Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Senseye Diagnostic Tool (DT) is the first listed.

NCT07280065 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Colorado, Georgia, Idaho.

Frequently Asked Questions

What is clinical trial NCT07280065 about?

NCT07280065 is a clinical study titled "REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool". 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 i...

What is the current status of trial NCT07280065?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,900 participants. The study started on 2026-02. Estimated completion is 2026-10.

What conditions does trial NCT07280065 study?

This clinical trial studies the following conditions: PTSD - Post Traumatic Stress Disorder.

What interventions are being tested in trial NCT07280065?

The interventions under investigation include: Senseye Diagnostic Tool (DT) (DEVICE), Clinician Administered PTSD Scale for DSM-5, Revised Version (BEHAVIORAL).

Who is sponsoring clinical trial NCT07280065?

This trial is sponsored by Senseye, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07280065 being conducted?

This trial has 6 study locations across Colorado, Georgia, Idaho, Massachusetts, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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