REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: Senseye, Inc.
You may qualify if…
- ✓ 1. The participant is willing and able to read, understand, and sign the approved Informed Consent Form (ICF).
- ✓ 2. Age 18 years old or older.
- ✓ 3. In the past month, participant presents with at least one of the following:
- ✓ nightmares or unwanted, intrusive thoughts
- ✓ avoidance of specific thoughts or situations
- ✓ feelings of being constantly on guard, watchful, or easily startled
- ✓ feeling numb or detached from people, activities, or surroundings; and/or
- ✓ persistent feelings of guilt or self blame for things that have happened.
You may not qualify if…
- ✕ 1. Current diagnosis of epilepsy and/or other seizure disorders.
- ✕ 2. A history of at Screening OR positive at Visit 1 for bipolar I or II, mania, or one or more schizophrenia-spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, delusional disorder, psychotic depression, and psychosis.
- ✕ 3. Compromised facial neuro-ophthalmic integrity (e.g., due to stroke, MS, ALS, or other neurological conditions).
- ✕ 4. Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus, posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitive dysfunction.
- ✕ 5. Current eye disorders which prevent the patient from using the Senseye DT:
- ✕ Vision impairment preventing ability to read with correction (including corneal disease, dense cataract, diabetic retinopathy, macular degeneration, glaucoma, etc.).
- ✕ Use of corrective lenses including glasses and contacts is permitted. Colored contacts and cosmetic lenses that obscure or enhance the pupil are not permitted.
- ✕ Significant eye lid droop blocking the pupil.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07280065 · last updated 2026-04-29