Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults With PTSD
Study Details
Study Description
Brief Summary
This pilot study will investigate the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of posttraumatic stress disorder (PTSD) symptoms and establish a "ground truth" for PTSD diagnosis and severity rating for the Senseye DT machine learning algorithm. A total of 350 adults will be included in the study with a follow-up time point of 12 weeks post-initial intervention.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This pilot study will investigate the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of posttraumatic stress disorder (PTSD) symptoms and establish a "ground truth" for PTSD diagnosis and severity rating for the Senseye DT machine learning algorithm. A total of 350 adults with and without PTSD will be included in the study with a follow-up time point of 12 weeks post-initial intervention.
Senseye DT neuropsychiatric measures will be measured at baseline and week 12. Using Senseye's machine learning algorithm, Senseye DT will use a phone app during a series of visual tasks, pupil light reflex, and heart rate measurement throughout.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PTSD positive Positive PTSD diagnosis |
Diagnostic Test: CAPS-5 Assessment
A validated, semi-structured clinical interview to assess core PTSD symptoms
Diagnostic Test: Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
|
| PTSD negative / trauma positive Patients diagnosed with significant trauma exposure but no PTSD |
Diagnostic Test: CAPS-5 Assessment
A validated, semi-structured clinical interview to assess core PTSD symptoms
Diagnostic Test: Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
|
| Healthy (trauma negative) Healthy w/o trauma exposure |
Diagnostic Test: CAPS-5 Assessment
A validated, semi-structured clinical interview to assess core PTSD symptoms
Diagnostic Test: Senseye DT
Using a machine learning algorithm, Senseye DT will record a series of visual tasks, pupil light reflex, vascular function and heart rate measurement throughout.
|
Outcome Measures
Primary Outcome Measures
- Agreement between Senseye DT and gold-standard measures at baseline [Baseline]
The Senseye DT demonstrates a statistically significant difference (p<0.05) between ocular signal, heart rate, and/or skin conductance data between PTSD+ and controls based on CAPS-5 scores at initial diagnosis.
- Agreement between Senseye DT and gold-standard measures at 12 weeks [12 weeks]
The Senseye DT demonstrates a statistically significant difference (p<0.05) between ocular signal, heart rate, and/or skin conductance data between PTSD+ and controls based on CAPS-5 scores at each follow-up time point.
- Establishment of Ground Truth [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.
- Time to Administer Tool [12 weeks]
The Senseye DT demonstrates significantly less time to administer than the Structured Clinical Interview and CAPS-5.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willing and able to read, understand, and sign the IRB-approved ICF.
-
Between the ages of 18 and 99.
-
PTSD population: Participant is diagnosed with PTSD
-
Non-PTSD population:
-
Participant is not diagnosed with PTSD or other DSM-5 psychiatric conditions, and without trauma exposure; or,
-
Participant is not diagnosed with PTSD but presents with positive traumatic exposure.
-
Able to read/write in English.
-
Participant is medically stable as determined by the clinician or investigator.
Exclusion Criteria:
-
Psychotic or self-injurious behavior.
-
Epilepsy or other seizure disorders.
-
Mania.
-
Primary diagnosis of bipolar, schizophrenia, autism, Parkinson's, or obsessive- compulsive disorders.
-
Compromised facial neuro-ophthalmic integrity
-
Eye disorders which prevent the patient from using the Senseye DT:
-
Vision impairment preventing ability to read with correction
-
Disorders requiring use of eye drops, except artificial tears.
-
Significant eye lid droop blocking the pupil.
-
Persistent blurry vision, headaches, and/or light sensitivity resulting from conditions including abnormal pupil dilation or reactivity
-
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 which may put the participant and/or others at risk as determined by the clinician or investigator.
-
Current reported usage of psychotropic drugs and medication which may affect use of the Senseye DT:
-
Narcotics/opioids
-
Tricyclic antidepressants
-
MAOIs
-
Select antihypertensive medications
-
Stimulants except caffeine or nicotine
-
Psychedelics/psychotomimetics
-
Cholinergic or anticholinergic agents
-
Spravato or Ketamine.
-
Any condition which precludes the ability for patients to complete clinical assessments, questionnaires, or to follow instructions necessary to administer the Senseye DT
-
Recent Traumatic Brain Injury (TBI) with vision changes lasting more than 24 hours.
-
Pregnant or intending on becoming pregnant during the duration of the study.
-
Currently incarcerated.
-
Participant requires a legal guardian to consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Senseye, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSP-PT-0003