Actively Recruiting
REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
Led by Senseye, Inc. · Updated on 2026-04-29
1900
Participants Needed
6
Research Sites
31 weeks
Total Duration
On this page
Sponsors
S
Senseye, Inc.
Lead Sponsor
L
Lindus Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant is willing and able to read, understand, and sign the approved Informed Consent Form (ICF).
- Age 18 years old or older.
- In the past month, participant has at least one symptom possibly related to PTSD, such as nightmares, avoidance, feeling on guard, numbness, persistent guilt, anxiety, sleep disturbance, depressed mood, loss of interest, weight/appetite changes, insomnia or hypersomnia, psychomotor changes, or abnormal fatigue.
- Deemed likely to comply with the study protocol including communication of adverse events, mental health history, treatments, and ability to attend all visits.
- Agrees to provide emergency contact information and physical location at each visit.
- Participant is psychologically stable as determined by the investigator.
- Has access to a device with stable internet and video call capability and a second smart device that is an iPhone 13 or newer (not including iPhone 13 Mini).
- Participant's home/environment meets criteria for Senseye DT setup for remote visits.
You will not qualify if you...
- Current diagnosis of epilepsy or other seizure disorders.
- History or positive screening for bipolar I or II, mania, schizophrenia-spectrum or other psychotic disorders.
- Compromised facial neuro-ophthalmic integrity due to neurological conditions.
- Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus, posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitive dysfunction.
- Eye disorders preventing use of Senseye DT, including vision impairment uncorrectable with lenses, significant eyelid droop, persistent blurry vision or light sensitivity, recent/planned eye surgeries, intraocular inflammation, or ocular trauma causing permanent damage.
- Active suicidal or homicidal intent or self-injurious behavior posing risk.
- Suicidal behavior within the last year or significant suicidal ideation within the last 6 months.
- Current use or planned use of certain psychotropic or non-psychotropic drugs affecting Senseye DT use, including narcotics, tricyclic antidepressants, MAOIs, stimulants, psychedelics, cholinergic/anticholinergic agents (except some antihistamines), Spravato/Ketamine, certain eye drops, CNS depressants.
- Current use or planned use of vagal nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, or other stimulation therapies.
- Conditions preventing safe and accurate completion of assessments or following instructions (e.g., developmental disabilities, language or cognitive disorders).
- Traumatic Brain Injury diagnosis within the last 12 months.
- Lifetime history of brain or meninges surgery, encephalitis, meningitis, degenerative CNS disorders, or other significant CNS injury or malfunction.
- Active litigation related to psychiatric symptoms.
- Pregnancy.
- Currently incarcerated.
- Requires a legal authorized representative to consent.
- Prior enrollment in this or other Senseye Machine Learning studies within the last 12 months.
- Unwilling or unable to comply with all study-related procedures as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Savannah VA Clinic
Savannah, Georgia, United States, 31419
Not Yet Recruiting
3
Velocity Clinical Research
Meridian, Idaho, United States, 83642
Actively Recruiting
4
Lindus Health (Virtual Study Site)
Boston, Massachusetts, United States, 02111
Actively Recruiting
5
Lowcountry Center for Veterans Research
Charleston, South Carolina, United States, 29403
Not Yet Recruiting
6
Zenko Clinical Pty Ltd (Virtual Study Site)
Carlton, Victoria, Australia, 3053
Actively Recruiting
Research Team
P
Priscilla Nechrebecki
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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