PTSDNCT05372523
Senseye's OBCI Diagnostic Tool for PTSD
An observational study of PTSD, run by Senseye, Inc. at 1 site in United States.
Trial summary
This pilot study will investigate the feasibility, acceptability, repeatability, accuracy and efficacy of the Senseye OBCI diagnostic tool to assess the presence and severity of PTSD symptoms and monitor response to trauma-informed interventions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- CAPS-5 Assessment and Senseye OBCI
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 11 Jan 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults presenting to the clinic with potential psychiatric disorder, to include PTSD
Who may be able to join
- Male/Female diagnosed with PTSD (only for PTSD group)
- aged 18- 65 years old
- able to read/write in English
Who cannot join
- presence of intellectual disabilities
- psychotic or self-injurious behavior
- seizure disorder
- major depression
- traumatic brain injury (TBI)
- language disorder
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- eye disorders
- other neurodevelopmental disorders
- history of lifetime psychosis
- mania
- current suicidality
- diagnosis of a substance use disorder
- impaired functioning to the degree that requires immediate initiation of psychotropic medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Olive View - UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: Pilot Investigation of Senseye's Ocular Brain-Computer Interface (OBCI) for Diagnosis of Adult With Post-Traumatic Stress Disorder (PTSD)
This pilot study will investigate the feasibility, acceptability, repeatability, accuracy and efficacy of the Senseye OBCI diagnostic tool to assess the presence and severity of PTSD symptoms and monitor response to trauma-informed interventions. A total of 68 adults will be included in the study with a follow-up time point of 9 weeks post-initial intervention.
Read the detailed description
This pilot study will investigate the feasibility, acceptability, repeatability, accuracy, and efficacy of operator-independent Senseye Ocular Brain-Computer Interface (OBCI) diagnostic tool to assess the presence and severity of PTSD symptoms and monitor response to trauma-informed interventions. After informed consent, 68 adults - 34 with PTSD and 17 adults with significant trauma exposure but no PTSD, and 17 healthy adults without known major psychiatric disorders, aged 18-65 years old, will be recruited and undergo OBCI diagnostic tool, comparing against gold standards tools- the CAPS-5, UCLA PTSD Reaction Index for DSM-5 (PTSD-RI). Fifteen participants will undergo repeatability and reproducibility assessments. Adults with PTSD will receive a standard of care trauma-informed interventions for eight weeks, and their biopsychosocial characteristics, Senseye OBCI, neuropsychiatric measures will be measured at baseline and week 9. Using Senseye's machine learning algorithm, Senseye OBCI will use a facecam recorder during a series of visual tasks, pupil light reflex, and heart rate measurement throughout.
- Conditions
- PTSD
- Being tested
- CAPS-5 Assessment, Senseye OBCI
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPS-5 AssessmentDiagnostic test
A validated, semi-structured clinical interview to assess core PTSD symptoms
Senseye OBCIDiagnostic test
Using a machine learning algorithm, Senseye's DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
| Study group | Role | What they receive |
|---|---|---|
| Trauma+ & PTSD | Patients diagnosed with significant trauma exposure and PTSD Receives: Diagnostic Test: CAPS-5 Assessment; Diagnostic Test: Senseye OBCI | |
| Trauma+ & No PTSD | Patients diagnosed with significant trauma exposure but no PTSD Receives: Diagnostic Test: CAPS-5 Assessment; Diagnostic Test: Senseye OBCI | |
| No trauma or PTSD | Healthy adults without known major psychiatric disorders Receives: Diagnostic Test: CAPS-5 Assessment; Diagnostic Test: Senseye OBCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between Senseye OBCI measures and gold-standard measures
Assessments for the presence and severity of PTSD symptoms will be compared between the Senseye tool and the gold-standard measures for percent agreement.
Measured: 9 weeks
Feasibility of the Senseye tool
Feasibility will be assessed by evaluating retention rate.
Measured: 9 weeks
Test-retest for repeatability of the Senseye tool
Senseye OBCI assessments will be repeated the same day and again at one week.
Measured: 1 week
Secondary outcomes (1)
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.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start25 Apr 2022
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Why it stopped: No participants completed study
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senseye, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naser Ahmadi, MD, Principal investigator, Olive View - UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372523
- Sponsor's protocol ID
- SEN-01-2022
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of Senseye's Ocular Brain-Computer Interface (OBCI) for Diagnosis of Adult With Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT05372523
- Acronym / sponsor ID
- SEN-01-2022
- Conditions
- PTSD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No participants completed study
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Senseye, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 12 May 2022 (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.
This pilot study will investigate the feasibility, acceptability, repeatability, accuracy and efficacy of the Senseye OBCI diagnostic tool to assess the presence and severity of PTSD symptoms and monitor response to trauma-informed interventions. A total of 68 adults will be included in the study with a follow-up time point of 9 weeks post-initial intervention.
Detailed description
This pilot study will investigate the feasibility, acceptability, repeatability, accuracy, and efficacy of operator-independent Senseye Ocular Brain-Computer Interface (OBCI) diagnostic tool to assess the presence and severity of PTSD symptoms and monitor response to trauma-informed interventions. After informed consent, 68 adults - 34 with PTSD and 17 adults with significant trauma exposure but no PTSD, and 17 healthy adults without known major psychiatric disorders, aged 18-65 years old, will be recruited and undergo OBCI diagnostic tool, comparing against gold standards tools- the CAPS-5, UCLA PTSD Reaction Index for DSM-5 (PTSD-RI). Fifteen participants will undergo repeatability and reproducibility assessments. Adults with PTSD will receive a standard of care trauma-informed interventions for eight weeks, and their biopsychosocial characteristics, Senseye OBCI, neuropsychiatric measures will be measured at baseline and week 9. Using Senseye's machine learning algorithm, Senseye OBCI will use a facecam recorder during a series of visual tasks, pupil light reflex, and heart rate measurement throughout.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trauma+ & PTSD | – | Diagnostic Test: CAPS-5 Assessment, Diagnostic Test: Senseye OBCIPatients diagnosed with significant trauma exposure and PTSD |
| Trauma+ & No PTSD | – | Diagnostic Test: CAPS-5 Assessment, Diagnostic Test: Senseye OBCIPatients diagnosed with significant trauma exposure but no PTSD |
| No trauma or PTSD | – | Diagnostic Test: CAPS-5 Assessment, Diagnostic Test: Senseye OBCIHealthy adults without known major psychiatric disorders |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting to the clinic with potential psychiatric disorder, to include PTSD
Key inclusion criteria (3 listed)
- Male/Female diagnosed with PTSD (only for PTSD group)
- aged 18- 65 years old
- able to read/write in English
Key exclusion criteria (13 listed)
- presence of intellectual disabilities
- psychotic or self-injurious behavior
- seizure disorder
- major depression
- traumatic brain injury (TBI)
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 AssessmentA validated, semi-structured clinical interview to assess core PTSD symptoms | Diagnostic test | No trauma or PTSD, Trauma+ & No PTSD, Trauma+ & PTSD |
| Senseye OBCIUsing a machine learning algorithm, Senseye's DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout. | Diagnostic test | No trauma or PTSD, Trauma+ & No PTSD, Trauma+ & PTSD |
Primary outcome
Agreement between Senseye OBCI measures and gold-standard measures
Time frame: 9 weeks
Assessments for the presence and severity of PTSD symptoms will be compared between the Senseye tool and the gold-standard measures for percent agreement.
Feasibility of the Senseye tool
Time frame: 9 weeks
Feasibility will be assessed by evaluating retention rate.
Test-retest for repeatability of the Senseye tool
Time frame: 1 week
Senseye OBCI assessments will be repeated the same day and again at one week.
1 secondary outcome
Prognostic value by comparing Senseye OBCI to core PTSD symptoms
Time frame: 9 weeks
Results and safety
The study was stopped early (reason given: No participants completed study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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.
Naser Ahmadi, MD principal investigator
Olive View - UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by Senseye, Inc. at 1 site 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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: No participants completed study). Results are not available in the source record.
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 OBCI measures and gold-standard measures (time frame: 9 weeks). The study lists 3 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 12 Apr 2023.