Senseye Diagnostic Tool for Post-Traumatic Stress Disorder

Not yet recruiting at 3 trial locations

Overseen By Priscilla Nechrebecki

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Senseye, Inc.

Must not be taking: Narcotics, Antidepressants, Stimulants, others

Disqualifiers: Epilepsy, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called Senseye DT (Senseye Diagnostic Tool) to evaluate its effectiveness in diagnosing Post-Traumatic Stress Disorder (PTSD). Participants will use the app, which analyzes video recordings to detect signs of PTSD, and researchers will compare the results to traditional clinical interviews. The study aims to determine the app's accuracy, its ability to predict PTSD severity, and whether it saves time compared to standard methods. This trial may suit adults who have experienced symptoms like nightmares, anxiety, or a depressed mood in the past month. Participants need access to an iPhone 13 or newer to join the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking diagnostic tool for PTSD.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before participating in the trial. Specifically, if you are using psychotropic drugs, certain antidepressants, stimulants, or other specified medications, you might need to stop them at least 24 hours before using the Senseye DT. Please check with the study team for specific guidance on your medications.

What prior data suggests that the Senseye Diagnostic Tool is safe for diagnosing PTSD?

Research has shown that the Senseye Diagnostic Tool (Senseye DT), an iPhone app for diagnosing PTSD, has been tested for effectiveness and accuracy. No reports of negative effects or side effects have emerged from using the app, which is expected since it is a software tool. The app uses the phone's camera to record video during tasks and employs machine learning to detect signs of PTSD.

Senseye DT is currently in a Phase 3 trial, indicating that earlier trials have already provided evidence of its safety. Researchers in those earlier stages ensured it would not cause harm. This is crucial because Phase 3 trials typically focus more on the tool's effectiveness than on safety.

Overall, while current studies primarily assess the accuracy and effectiveness of Senseye DT, the absence of reported negative effects so far suggests it is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Senseye Diagnostic Tool for PTSD because it offers a novel approach to diagnosing the condition. Unlike traditional methods that often rely heavily on subjective clinical assessments, the Senseye tool may provide a more objective and potentially faster way to determine PTSD presence and severity. This new method could lead to more accurate diagnoses, ensuring patients receive the appropriate care more quickly. By streamlining the diagnostic process, the Senseye tool has the potential to improve outcomes for individuals suffering from PTSD.

What evidence suggests that the Senseye Diagnostic Tool is effective for diagnosing PTSD?

Research shows that the Senseye Diagnostic Tool (Senseye DT) might be a promising way to detect PTSD. In this trial, all participants will undergo assessment with both the Senseye DT and the CAPS-5-R, the clinical reference standard for PTSD. Previous studies have evaluated the effectiveness of the Senseye DT by comparing it to the main symptoms of PTSD to determine if it matches current clinical methods. The tool uses an iPhone app to record video while participants perform tasks, and a computer program analyzes the video to detect signs of PTSD. This method has been studied for its ability to identify both the presence and severity of PTSD. Early results suggest that Senseye could offer a faster and more convenient option than traditional diagnostic interviews. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults 18+ with symptoms of PTSD, who can attend virtual visits and possibly an in-person session if near a study site. Exclusion criteria are not specified but typically would include factors that could interfere with the diagnostic tool's assessment or individuals' ability to participate fully.

Inclusion Criteria

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

I am 18 years old or older.

The participant is willing and able to read, understand, and sign the approved Informed Consent Form (ICF)

Exclusion Criteria

I have epilepsy or another seizure disorder.

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, compromised facial neuro-ophthalmic integrity, 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, active suicidal and/or homicidal intent or other self-injurious behavior, suicidal behavior within the last year, significant suicidal ideation within the last 6 months, current reported usage of specific drugs and medications, current reported usage of vagal nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, or other stimulation or energy-based therapies, 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, medical diagnosis of Traumatic Brain Injury (TBI) within the last 12 months, lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder, involvement in active litigation related to the participant's psychiatric symptoms, pregnancy, current incarceration, participant requiring a legal authorized representative to consent, prior enrollment in this study or in other Senseye Machine Learning (ML) studies within the last 12 months, unwilling or unable to comply with all study related procedures in the opinion of the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Assessment

Participants undergo standard mental health assessments including SIGMA, SIGH-A, MINI, and possibly CAPS-5-R

1 week

1 visit (virtual)

Senseye DT Testing

Participants use the Senseye DT app to perform tasks while being recorded for PTSD diagnostic testing

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for any adverse effects and satisfaction with the Senseye DT

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Senseye Diagnostic Tool

Trial Overview

The REVEAL study is testing the Senseye Diagnostic Tool, an iPhone app using machine learning to diagnose PTSD by analyzing videos recorded during tasks. It compares this tool's accuracy and speed against structured clinical interviews like SIGMA, SIGH-A, MINI Interview, and CAPS-5-R.

How Is the Trial Designed?

Group I: PTSD assessment comparing the Senseye DT to the clinical reference standard Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Senseye, Inc.

Lead Sponsor

Trials

2

Recruited

400+

Lindus Health

Industry Sponsor

Trials

12

Recruited

17,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07280065?lastUpdPost=2020-01-16_

REVEAL Study - Diagnostic Testing for PTSD Using the ...

The order of administration will be randomized. Intervention/Treatment, Device : Senseye Diagnostic Tool (DT). Software ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05717439

Feasibility and ML Training Investigation of the Senseye ...

The aim of this study is to obtain data on the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of post-traumatic stress ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05372523

NCT05372523 | Senseye's OBCI Diagnostic Tool for PTSD

Prognostic value by comparing Senseye OBCI to core PTSD symptoms, Analyses of data collected on the Senseye tool will be compared with the core PTSD symptoms.

4.

megadoctornews.com

megadoctornews.com/dhr-health-institute-of-research-and-development-launches-clinical-trial-for-senseye/

DHR Health Institute of Research Launches Clinical Trial ...

... software as a diagnostic tool for Post Traumatic Stress Disorder. The software tool, called Senseye, looks to revolutionize the way in which ...

5.

homebase.org

homebase.org/research-studies/

Research Studies | Home Base

Sponsor: Senseye Inc. Objective: To obtain data on the feasibility of a new smartphone app / software product – the Senseye Diagnostic Tool (DT) – to assess the ...

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05717439/feasibility-and-ml-training-investigation-of-the-senseye-dt-for-diagnosis-of-adults-with-ptsd

Feasibility and ML Training Investigation of the Senseye ...

The aim of this study is to obtain data on the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of post-traumatic stress ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11818450/

Effects of trauma exposure and posttraumatic stress disorder ...

The aim of this study was to examine relationships among trauma burden, post-traumatic stress disorder, and perceived social support in a large, diverse group ...