PTSDNCT05717439
Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults with PTSD
An observational study of PTSD and Generalized Anxiety Disorder, run by Senseye, Inc. at 5 sites in United States.
Trial summary
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 disorder (PTSD) symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD, Generalized Anxiety Disorder, Major Depressive Disorder
- What is being tested?
- CAPS-5-R and Senseye DT
- How many people
- 338 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Mar 2023to 25 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with or without PTSD, Generalized Anxiety Disorder (GAD), and/or Major Depressive Disorder (MDD)
Who may be able to join
- Willing and able to read, understand, and sign the IRB-approved Informed Consent Form.
- Age 18+.
- Study groups: Diagnosed with PTSD, GAD, and/or MDD.
- Control groups: Not diagnosed with PTSD, GAD, or MDD.
- Deemed likely to comply with the study protocol, including willing communication of adverse events (AEs), mental health treatment history, current and past psychiatric medication, and ability to attend all study follow-up visits.
- Medically stable as determined by the clinician or investigator.
- Virtual sites: Subject has access to a stable internet and WIFI connection and an iPhone 11 or newer.
Who cannot join
- Psychotic or self-injurious behavior.
- Current diagnosis of epilepsy and/or other current seizure disorders.
- A history of or positive at screening for bipolar I or II, mania, or one or more schizophrenia-spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, delusional disorder, 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 (complete list in full protocol).
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- Active suicidal and/or homicidal intent which may put the participant and/or others at risk per the investigator's clinical judgement, or has suicidal ideation with intent to act within 6 months prior to the start of the screening phase as determined by a C-SSRS score > 3, or history of suicidal behavior within the past year prior to the start of the screening phase.
- Current reported usage (within 2 weeks of Initial Study Visit and/or planned ongoing usage during the study) of psychotropic and/or non-psychotropic drugs/medication which may affect use of the Senseye DT (complete list in full protocol).
- Current reported usage (within 2 weeks of Initial Study Visit and/or planned ongoing usage during the study) of vagal nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, or electroconvulsive therapy.
- Any condition which precludes the ability for subjects 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).
- Traumatic Brain Injury (TBI) within the last 12 months.
- 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), epilepsy, mental retardation, or any other disease/procedure/accident/intervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS.
- Pregnant or intending on becoming pregnant during the duration of the study as determined by self-report.
- Currently incarcerated.
- Participant requires a legal guardian to consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 29401
Future Search Trials
Dallas, Texas, 75231
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Velocity Clinical Research
Meridian, Idaho, 83642
About this study
Official title: Machine-Learning Training Study of the Senseye Diagnostic Tool for Diagnosis of Adults with Post-Traumatic Stress Disorder (PTSD), Anxiety, and Depression
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 disorder (PTSD) symptoms. The study will also collect data on Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD) to aid in assessing the presence and severity of these disorders both for the purpose of discerning them from PTSD and determining the feasibility of diagnosing them independently.
Read the detailed description
This clinical study will be conducted to inform and train the Senseye DT's machine learning algorithm, to be evaluated in a future study for effectiveness in identifying people with PTSD compared to the Clinician-Administered PTSD Scale for DSM-5, revised version (CAPS-5-R) assessment. The Senseye DT is designed to utilize video data captured from a subject's eyes while they are presented various visual stimuli to extract ocular metrics (i.e., pupil size, gaze pattern, etc.) and heart rate data and use this information to detect the presence and severity of PTSD. Due to the overlapping symptomatology between PTSD, GAD, and MDD and common elements of ANS abnormalities (e.g., hyperarousal in both PTSD and GAD), it is necessary for the Senseye DT's specificity to discern between PTSD, GAD and MDD. This study is therefore designed to fully assess the presence and severity of each of these disorders in subjects to ensure device specificity as well as to test the feasibility to diagnose and rate severity of these conditions.
The study will be divided into two concurrent phases:
Phase I will focus on assessing the presence of PTSD via Screening through Baseline Study Visits. The objective of this phase is to obtain an accurate baseline diagnosis and severity rating for PTSD using Standard of Care methods and to use the Senseye DT to obtain data necessary for the device to be trained to produce a PTSD diagnosis. Baseline diagnosis and severity of GAD and MDD will also be determined.
Phase II will focus on assessing the severity of PTSD symptoms over time, with the objective to collect data necessary to train the Senseye DT machine learning algorithm to accurately determine a subject's PTSD severity rating correlated to the CAPS-5-R. Phase II consists of follow-up time points of 4 weeks, 8 weeks, and 12 weeks, and assesses changes in PTSD since the baseline severity determined in Phase I. Changes in GAD and MDD from baseline will also be assessed.
- Being tested
- CAPS-5-R, Senseye DT
- Medical subject headings
- Stress Disorders, Post-Traumatic, Generalized Anxiety Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPS-5-RDiagnostic test
Also called Clinician-Administered Scale for PTSD for DSM-5, Revised version
A semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating.
Senseye DTDiagnostic test
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
| Study group | Role | What they receive |
|---|---|---|
| PTSD positive | Subjects meet criteria for PTSD, with or without comorbid Generalized Anxiety Disorder or Major Depressive Disorder Receives: Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT | |
| Primary GAD | Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder Receives: Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT | |
| Primary MDD | Subjects DO NOT meet criteria for PTSD, but meet criteria for Major Depressive Disorder Receives: Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT | |
| Comorbid GAD/MDD | Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder and Major Depressive Disorder Receives: Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT | |
| Trauma-positive, PTSD/GAD/MDD-negative | Subjects have trauma exposure meeting DSM-5-TR Criterion A, but DO NOT meet criteria for PTSD, GAD, or MDD Receives: Diagnostic Test: CAPS-5-R; Diagnostic Test: Senseye DT | |
| Trauma-negative | Subjects DO NOT have trauma exposure meeting DSM-5-TR Criterion A and DO NOT meet criteria for PTSD, GAD, or MDD Receives: Diagnostic Test: Senseye DT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between Senseye DT and CAPS-5-R assessment at baseline
The Senseye DT demonstrates a statistically significant difference (p<0.05) of ocular signal and/or heart rate data between subjects with PTSD and/or GAD and/or MDD and control subjects at Baseline. Senseye DT results and clinical assessment diagnosis results will be compared using a 2-sample t-test or Wilcoxon rank-sum test.
Measured: Baseline
Agreement between Senseye DT and CAPS-5-R at 12 weeks
The Senseye DT demonstrates a statistically significant difference (p<0.05) of ocular signal and/or heart rate data between subjects with PTSD and/or GAD and/or MDD and control subjects at the 12-week follow-up time point. Senseye DT results and clinical assessment diagnosis results will be compared using a 2-sample t-test or Wilcoxon rank-sum test.
Measured: 12 weeks
Establishment of Ground Truth - PTSD
To obtain data using the Senseye DT measures in both PTSD and control subjects to establish a "ground truth" for the Senseye DT's machine learning algorithm to use for objectively diagnosing and ranking severity of PTSD.
Measured: Baseline & 12 weeks
Establishment of Ground Truth - GAD/MDD
To obtain data using the Senseye DT to establish a "ground truth" for the Senseye DT's machine learning algorithm to use for objectively diagnosing and ranking severity of GAD and/or MDD.
Measured: Baseline & 12 weeks
Secondary outcomes (1)
Time to Administer Tool
The Senseye DT demonstrates significantly less time to administer than the CAPS-5-R, based on actual recorded time for study staff to administer each assessment. Senseye DT time and CAPS-5-R time will be compared using a 2-sample t-test or Wilcoxon rank-sum test.
Measured: Baseline & 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Mar 2023
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senseye, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717439
- Sponsor's protocol ID
- CSP-PT-0003
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine-Learning Training Study of the Senseye Diagnostic Tool for Diagnosis of Adults with Post-Traumatic Stress Disorder (PTSD), Anxiety, and Depression
- ClinicalTrials.gov ID
- NCT05717439
- Acronym / sponsor ID
- CSP-PT-0003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Senseye, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 disorder (PTSD) symptoms. The study will also collect data on Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD) to aid in assessing the presence and severity of these disorders both for the purpose of discerning them from PTSD and determining the feasibility of diagnosing them independently.
Detailed description
This clinical study will be conducted to inform and train the Senseye DT's machine learning algorithm, to be evaluated in a future study for effectiveness in identifying people with PTSD compared to the Clinician-Administered PTSD Scale for DSM-5, revised version (CAPS-5-R) assessment. The Senseye DT is designed to utilize video data captured from a subject's eyes while they are presented various visual stimuli to extract ocular metrics (i.e., pupil size, gaze pattern, etc.) and heart rate data and use this information to detect the presence and severity of PTSD. Due to the overlapping symptomatology between PTSD, GAD, and MDD and common elements of ANS abnormalities (e.g., hyperarousal in both PTSD and GAD), it is necessary for the Senseye DT's specificity to discern between PTSD, GAD and MDD. This study is therefore designed to fully assess the presence and severity of each of these disorders in subjects to ensure device specificity as well as to test the feasibility to diagnose and rate severity of these conditions.
The study will be divided into two concurrent phases:
Phase I will focus on assessing the presence of PTSD via Screening through Baseline Study Visits. The objective of this phase is to obtain an accurate baseline diagnosis and severity rating for PTSD using Standard of Care methods and to use the Senseye DT to obtain data necessary for the device to be trained to produce a PTSD diagnosis. Baseline diagnosis and severity of GAD and MDD will also be determined.
Phase II will focus on assessing the severity of PTSD symptoms over time, with the objective to collect data necessary to train the Senseye DT machine learning algorithm to accurately determine a subject's PTSD severity rating correlated to the CAPS-5-R. Phase II consists of follow-up time points of 4 weeks, 8 weeks, and 12 weeks, and assesses changes in PTSD since the baseline severity determined in Phase I. Changes in GAD and MDD from baseline will also be assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PTSD positive | – | Diagnostic Test: CAPS-5-R, Diagnostic Test: Senseye DTSubjects meet criteria for PTSD, with or without comorbid Generalized Anxiety Disorder or Major Depressive Disorder |
| Primary GAD | – | Diagnostic Test: CAPS-5-R, Diagnostic Test: Senseye DTSubjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder |
| Primary MDD | – | Diagnostic Test: CAPS-5-R, Diagnostic Test: Senseye DTSubjects DO NOT meet criteria for PTSD, but meet criteria for Major Depressive Disorder |
| Comorbid GAD/MDD | – | Diagnostic Test: CAPS-5-R, Diagnostic Test: Senseye DTSubjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder and Major Depressive Disorder |
| Trauma-positive, PTSD/GAD/MDD-negative | – | Diagnostic Test: CAPS-5-R, Diagnostic Test: Senseye DTSubjects have trauma exposure meeting DSM-5-TR Criterion A, but DO NOT meet criteria for PTSD, GAD, or MDD |
| Trauma-negative | – | Diagnostic Test: Senseye DTSubjects DO NOT have trauma exposure meeting DSM-5-TR Criterion A and DO NOT meet criteria for PTSD, GAD, or MDD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with or without PTSD, Generalized Anxiety Disorder (GAD), and/or Major Depressive Disorder (MDD)
Key inclusion criteria (7 listed)
- Willing and able to read, understand, and sign the IRB-approved Informed Consent Form.
- Age 18+.
- Study groups: Diagnosed with PTSD, GAD, and/or MDD.
- Control groups: Not diagnosed with PTSD, GAD, or MDD.
- Deemed likely to comply with the study protocol, including willing communication of adverse events (AEs), mental health treatment history, current and past psychiatric medication, and ability to attend all study follow-up visits.
Key exclusion criteria (15 listed)
- Psychotic or self-injurious behavior.
- Current diagnosis of epilepsy and/or other current seizure disorders.
- A history of or positive at screening for bipolar I or II, mania, or one or more schizophrenia-spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, delusional disorder, 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPS-5-RAlso: Clinician-Administered Scale for PTSD for DSM-5, Revised versionA semi-structured clinical interview to assess core PTSD symptoms for diagnosis and severity rating. | Diagnostic test | Comorbid GAD/MDD, PTSD positive, Primary GAD, Primary MDD, Trauma-positive, PTSD/GAD/MDD-negative |
| Senseye DTUsing a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout. | Diagnostic test | Comorbid GAD/MDD, PTSD positive, Primary GAD, Primary MDD, Trauma-negative, Trauma-positive, PTSD/GAD/MDD-negative |
Primary outcome
Agreement between Senseye DT and CAPS-5-R assessment at baseline
Time frame: Baseline
The Senseye DT demonstrates a statistically significant difference (p<0.05) of ocular signal and/or heart rate data between subjects with PTSD and/or GAD and/or MDD and control subjects at Baseline. Senseye DT results and clinical assessment diagnosis results will be compared using a 2-sample t-test or Wilcoxon rank-sum test.
Agreement between Senseye DT and CAPS-5-R at 12 weeks
Time frame: 12 weeks
The Senseye DT demonstrates a statistically significant difference (p<0.05) of ocular signal and/or heart rate data between subjects with PTSD and/or GAD and/or MDD and control subjects at the 12-week follow-up time point. Senseye DT results and clinical assessment diagnosis results will be compared using a 2-sample t-test or Wilcoxon rank-sum test.
Establishment of Ground Truth - PTSD
Time frame: Baseline & 12 weeks
To obtain data using the Senseye DT measures in both PTSD and control subjects to establish a "ground truth" for the Senseye DT's machine learning algorithm to use for objectively diagnosing and ranking severity of PTSD.
Establishment of Ground Truth - GAD/MDD
Time frame: Baseline & 12 weeks
To obtain data using the Senseye DT to establish a "ground truth" for the Senseye DT's machine learning algorithm to use for objectively diagnosing and ranking severity of GAD and/or MDD.
1 secondary outcome
Time to Administer Tool
Time frame: Baseline & 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Generalized Anxiety Disorder, run by Senseye, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between Senseye DT and CAPS-5-R assessment at baseline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.