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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

Diagnostic Testing of Post-Traumatic Stress Disorder (PTSD) Using the Senseye Diagnostic Tool in Adults : United States, Australia, and Decentralized Trial (DCT) Protocol

REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool (NCT07280065) is a Phase 3 interventional studying PTSD - Post Traumatic Stress Disorder, sponsored by Senseye, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For PTSD - Post Traumatic Stress Disorder, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 1,900 participants makes this one of the larger PTSD - Post Traumatic Stress Disorder trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The participant is willing and able to read, understand, and sign the approved willing to sign a consent form 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. - 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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. * 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 Criteria: 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. * 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. Stimulants (e.g., Amphetamines, Ritalin, Focalin, pseudoephedrine/Sudafed, ecstasy, cocaine, methamphetamines, cathinones, etc.). Note: Caffeine or nicotine use is not exclusionary. Note: that if Sudafed, pseudoephedrine, and stimulants commonly used to treat ADHD (e.g., Ritalin, Focalin, Adderall, etc. can be abstained from for \> 24 hours prior to the Senseye DT visit, the exclusion does not apply for those medications. * 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.

Treatments Being Tested

DEVICE

Senseye Diagnostic Tool (DT)

Software as a Medical Device - the Senseye DT is an investigational diagnostic device that is an application which can be installed on iPhones 13 and newer. The device administers various tasks on the phone screen that the participant completes while video and/or audio is recorded (depending on the task). Recordings are analyzed by a machine learning algorithm to predict the presence and severity of PTSD.

BEHAVIORAL

Clinician Administered PTSD Scale for DSM-5, Revised Version

The CAPS-5-R is a standardized stuctured clinical interview for determining PTSD presence and severity. It is a behavioral interview administered by a trained mental health clinician or clinical rater. Participant responses to various questions about traumatic experiences and resulting symptoms are scored to determine PTSD presence according to DSM-5 criteria and PTSD severity according to the CAPS-5-R severity scale.

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Savannah VA Clinic
Savannah, Georgia, United States
Velocity Clinical Research
Meridian, Idaho, United States
Lindus Health (Virtual Study Site)
Boston, Massachusetts, United States
Lowcountry Center for Veterans Research
Charleston, South Carolina, United States
Zenko Clinical Pty Ltd (Virtual Study Site)
Carlton, Victoria, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07280065), the sponsor (Senseye, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07280065 clinical trial studying?

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 stu… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07280065?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07280065?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07280065. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07280065. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.