REVEAL Study: Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
The REVEAL study is looking at a new way to diagnose Post-traumatic Stress Disorder (PTSD) using an iPhone app called the Senseye Diagnostic Tool (DT). This app runs tasks on your phone while recording video, and an Artificial Intelligence (AI) program analyzes these recordings for signs of PTSD. The study aims to see how well the Senseye DT can accurately identify PTSD compared to a standard interview (CAPS-5-R). You might be able to join if you are 18 or older and have experienced symptoms like nightmares, intrusive thoughts, avoiding certain situations, or feeling constantly on guard in the past month. The study will measure how accurate the Senseye DT is at the beginning of the study.
- Study design
- This is an interventional study planning to enroll 1900 participants. It is testing a new diagnostic device.
- What's involved
- You would use the Senseye DT iPhone app, which administers tasks while recording video. You would also have a standardized clinical interview (CAPS-5-R) with a mental health clinician.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is to measure the accuracy of the Senseye DT at the start of the study (Baseline).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07280065
REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
Recruiting
PHASE3Ages 18+InterventionalDiagnosticSenseye, Inc.
~1,900 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Senseye Diagnostic Tool (DT)Clinician Administered PTSD Scale for DSM-5, Revised Version
At a glance
Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and Specificity of the Senseye DT as an objective PTSD diagnostic test
Measured over Baseline
Conditions
Where it's being run
6 sites across 6 statesColorado1
Georgia1
Idaho1
Massachusetts1
South Carolina1
Victoria1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
excessive anxiety and worry (apprehensive expectation), occurring more days than not for at least 6 months, about a number of events or activities (such as work or school performance)
sleep disturbance (difficulty falling or staying asleep, or restless unsatisfying sleep)
depressed mood: most of the day, nearly every day, feeling sad, empty, or hopeless
markedly diminished interest or pleasure in activities: loss of interest or pleasure in most activities, nearly every day
self-report of significant weight loss or gain and/or changes in appetite
insomnia or hypersomnia: sleeping too little or too much
psychomotor agitation or retardation: observable restlessness or slowed movements
abnormal fatigue or loss of energy: feeling tired or lacking energy more than usual 4. Deemed likely to comply with the study protocol by the study team, including willing communication of adverse events (AEs), mental health history, current and past psychiatric medication \& treatments, and ability to attend all study visits. 5. Participant agrees to provide emergency contact information at Screening Visit and their physical location at each visit (if they are joining the visit remotely). 6. Participant is psychologically stable as determined by the investigator or delegate. 7. Participant has access to the following:
a device with stable internet and Wi-Fi connection capable of supporting video calls (e.g., tablet, computer with webcam, etc.)
a second smart device that must be an iPhone 13 or newer (Not inclusive of the iPhone13 Mini) 8. Participant home/environment meets criteria for Senseye DT setup (remote visits only)
Exclusion
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.
Persistent blurry vision, headaches, and/or light sensitivity resulting from conditions including abnormal pupil dilation or reactivity (e.g, mydriasis).
Recent eye surgeries (within 2 weeks) or planned eye surgeries within the study duration.
Intraocular inflammation, including iritis and anterior uveitis.
Ocular trauma resulting in uncorrected or permanent bilateral damage. 6. Active suicidal and/or homicidal intent or other self-injurious behavior which may put the participant and/or others at risk per the investigator's clinical judgement, or has suicidal ideation of level 4 or 5 as determined by the C-SSRS. 7. Suicidal behavior within the last year as determined by the C-SSRS at the time of screening. 8. Significant suicidal ideation within the last 6 months as determined by ideation of level 4 or 5 by the C-SSRS at the time of screening. 9. Current reported usage (within 2 weeks of Screening Visit and/or planned ongoing usage during the study) of psychotropic drugs and/or non-psychotropic drugs or medication which may affect use of the Senseye DT:
Narcotics/opioids (e.g., Heroin, Vicodin, oxycodone, codeine, Tramadol, etc.).
Tricyclic antidepressants (TCAs) (e.g., Tofranil, Pamelor, amitriptyline, doxeprin, etc.).
Monoamine Oxidase Inhibitors (MAOIs) (e.g., Emsam, Parnate, Nardil, Marplan, etc.).
Select antihypertensive medications (alpha-2 receptor agonists, clonidine, peripheral adrenergic inhibitors, Alpha \& Beta blockers, and Rauwolfia alkaloids). Note: If Prazosin can be abstained from for \> 24 hours prior to the Senseye DT visit, the exclusion does not apply for that medication.
Psychedelics/psychotomimetics (Lysergic acid, psilocybin, mescaline, phencyclidine, methoxetamine, etc.).
Cholinergic or anticholinergic agents (e.g., Urecholine, Pilocar, Aricept, Miostat, Evoxac, ipratropium/Atrovent, oxybutynin/Ditropan, scopolamine, etc.), except antihistamines other than Benadryl or diphenhydramine. Note: If Benadryl/diphenhydramine can be abstained from for \> 24 hours prior to the Senseye DT visit, the exclusion does not apply.
Spravato or Ketamine.
Eye drops unless the participant is able to abstain from use for \> 72 hours prior to the Senseye DT visit. Note: Artificial tears can be used if needed during the Senseye DT use.
Central Nervous System (CNS) depressants (Benzodiazepines and Barbiturates) 10. Current reported usage (within 2 weeks of Screening Visit and/or planned ongoing usage during the study) of vagal nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, or other stimulation or energy-based therapies. 11. Any condition which precludes the ability for patients to safely and accurately complete clinical assessments, questionnaires, or to follow instructions necessary to administer the Senseye DT (e.g., significant developmental disabilities, language disorders, cognitive deficiencies, or other neurodevelopmental disorders). 12. Medical diagnosis of Traumatic Brain Injury (TBI) within the last 12 months based on participant self-report. 13. Lifetime history of any of the following: surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), or any other disease/procedure/accident/intervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS. 14. Involved in active litigation related to the participant's psychiatric symptoms 15. Pregnancy as determined by self-report. 16. Currently incarcerated. 17. Participant requires a legal authorized representative to consent. 18. Prior enrollment in this study or in other Senseye Machine Learning (ML) studies within the last 12 months. 19. Unwilling or unable to comply with all study related procedures, in the opinion of the investigator, including medical and non-medical procedures.
What this trial measures
- Sensitivity and Specificity of the Senseye DT as an objective PTSD diagnostic testBaseline
Performance goals (lower bound of 95% confidence intervals) are set to ≥0.70 sensitivity and ≥0.70 specificity for the device's binary PTSD diagnostic test result as compared to the Clinical Reference Standard. The Senseye DT would provide a clear, objective diagnostic result that is 70% of the research-quality structured clinical interview accuracy (70% of 100% accuracy). This level of accuracy is clinically sufficient for providing a meaningful diagnostic output for PTSD as it provides an accuracy equivalent to current standard-of-care methods in mental healthcare. In primary care settings where a majority of PTSD patients are initially seen for symptoms, the Senseye DT would provide a 50% improvement in accuracy compared to current methods (70% vs. 20%).