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REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
NCT07280065 · View on ClinicalTrials.gov ↗
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,900 participants |
| Start Date | 2026-02 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07280065
The ClinicalTrials.gov registry entry for NCT07280065 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Senseye, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07280065 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Colorado, Georgia, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07280065?
This trial is sponsored by Senseye, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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