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

NCT07280065 | Recruiting Phase 3 FDA Device

• 1 other identifier: CSP-002
• Study Type: interventional
• Target: 1,900
• Locations: 2 countries
• Sites: 6

Brief 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:

• 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

PTSD - Post Traumatic Stress Disorder

Keywords

PTSD; Trauma; MDD; Depression; GAD; Anxiety; Nightmares; Major Depressive Disorder; Avoidance

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of the Senseye DT as an objective PTSD diagnostic test

  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%).

  Baseline

Secondary Outcomes (3)

• Time to administer the Senseye DT compared to the clinical reference standard

  Baseline

• Agreement between the Senseye DT PTSD severity score output and the CAPS-5-R severity scale

  Baseline

• To demonstrate the Senseye DT's clinical utility in identifying individuals recommended for treatment intervention for PTSD, as assessed by an independent clinician panel.

  Baseline

Other Outcomes (3)

• Number of Serious Adverse Device Effects (SADEs).

  Baseline to study completion, an average of 2 weeks.

• Device positive predictive value (PPV) and negative predictive value (NPV).

  Baseline

• Participant satisfaction for using the Senseye DT compared to the CAPS-5-R structured clinical interview.

  Baseline

Study Arms (1)

PTSD assessment comparing the Senseye DT to the clinical reference standard

EXPERIMENTAL

All participants enrolled will be administered both the Senseye DT and the CAPS-5-R. The CAPS-5-R is used as the study's clinical reference standard to establish the "ground truth" for PTSD presence and severity. The order of administration will be randomized.

Device: Senseye Diagnostic Tool (DT); Behavioral: Clinician Administered PTSD Scale for DSM-5, Revised Version

Interventions

Clinician Administered PTSD Scale for DSM-5, Revised Version BEHAVIORAL

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.

Also known as: CAPS-5-R

PTSD assessment comparing the Senseye DT to the clinical reference standard

Senseye Diagnostic Tool (DT) DEVICE

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.

PTSD assessment comparing the Senseye DT to the clinical reference standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• Current diagnosis of epilepsy and/or other seizure disorders.
• 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.
• Compromised facial neuro-ophthalmic integrity (e.g., due to stroke, MS, ALS, or other neurological conditions).
• Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus, posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitive dysfunction.
• 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.
• 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.
• Suicidal behavior within the last year as determined by the C-SSRS at the time of screening.
• 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.

Sponsors & Collaborators

• Senseye, Inc.: lead
• Lindus Health: collaborator
• Medtryx Pty Ltd: collaborator

Study Sites (6)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Savannah VA Clinic

Savannah, Georgia, 31419, United States

NOT YET RECRUITING

Velocity Clinical Research

Meridian, Idaho, 83642, United States

RECRUITING

Lindus Health (Virtual Study Site)

Boston, Massachusetts, 02111, United States

RECRUITING

Lowcountry Center for Veterans Research

Charleston, South Carolina, 29403, United States

NOT YET RECRUITING

Zenko Clinical Pty Ltd (Virtual Study Site)

Carlton, Victoria, 3053, Australia

RECRUITING

Related Links

• Senseye, Inc. Website (Study Sponsor)

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Wounds and Injuries; Depression; Anxiety Disorders; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders

Central Study Contacts

Priscilla Nechrebecki

CONTACT

(833) 459-9365; REVEALPTSD@lindushealth.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to mask the intervention being given to participants. However, during the pivotal (test validation) phase of the study, investigators and the sponsor will be masked/blinded to the intervention output (PTSD results). Participants will always be masked/blinded to the intervention output.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be evaluated for PTSD presence and severity using both the CAPS-5-R structured clinical interview \[the clinical reference standard\] and the Senseye Diagnostic Tool (DT) \[the study device\]. The order of these interventions will be randomized - some participants will be assessed with the CAPS-5-R first and Senseye DT second, while others will be assessed with the Senseye DT first and CAPS-5-R second.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 12, 2025
• Study Start: February 23, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); AU (1)