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

Inclusion Criteria:

1. The participant is willing and able to read, understand, and sign the approvedInformed Consent Form (ICF).

2. Age 18 years old or older.

3. 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 daysthan not for at least 6 months, about a number of events or activities (such aswork or school performance)

• sleep disturbance (difficulty falling or staying asleep, or restlessunsatisfying sleep)

• depressed mood: most of the day, nearly every day, feeling sad, empty, orhopeless

• markedly diminished interest or pleasure in activities: loss of interest orpleasure 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 slowedmovements

• abnormal fatigue or loss of energy: feeling tired or lacking energy more thanusual

4. Deemed likely to comply with the study protocol by the study team, including willingcommunication of adverse events (AEs), mental health history, current and pastpsychiatric medication & treatments, and ability to attend all study visits.

5. Participant agrees to provide emergency contact information at Screening Visit andtheir physical location at each visit (if they are joining the visit remotely).

6. Participant is psychologically stable as determined by the investigator or delegate.

7. Participant has access to the following:

• a device with stable internet and Wi-Fi connection capable of supporting videocalls (e.g., tablet, computer with webcam, etc.)

• a second smart device that must be an iPhone 13 or newer (Not inclusive of theiPhone13 Mini)

8. Participant home/environment meets criteria for Senseye DT setup (remote visitsonly)

Exclusion Criteria:

1. Current diagnosis of epilepsy and/or other seizure disorders.

2. A history of at Screening OR positive at Visit 1 for bipolar I or II, mania, or oneor more schizophrenia-spectrum or other psychotic disorders, includingschizophrenia, schizoaffective disorder, delusional disorder, psychotic depression,and psychosis.

3. Compromised facial neuro-ophthalmic integrity (e.g., due to stroke, MS, ALS, orother neurological conditions).

4. Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus,posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitivedysfunction.

5. Current eye disorders which prevent the patient from using the Senseye DT:

• Vision impairment preventing ability to read with correction (including cornealdisease, dense cataract, diabetic retinopathy, macular degeneration, glaucoma,etc.).

• Use of corrective lenses including glasses and contacts is permitted. Coloredcontacts and cosmetic lenses that obscure or enhance the pupil are notpermitted.

• Significant eye lid droop blocking the pupil.

• Persistent blurry vision, headaches, and/or light sensitivity resulting fromconditions including abnormal pupil dilation or reactivity (e.g, mydriasis).

• Recent eye surgeries (within 2 weeks) or planned eye surgeries within the studyduration.

• Intraocular inflammation, including iritis and anterior uveitis.

• Ocular trauma resulting in uncorrected or permanent bilateral damage.

6. Active suicidal and/or homicidal intent or other self-injurious behavior which mayput 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.

7. Suicidal behavior within the last year as determined by the C-SSRS at the time ofscreening.

8. Significant suicidal ideation within the last 6 months as determined by ideation oflevel 4 or 5 by the C-SSRS at the time of screening.

9. Current reported usage (within 2 weeks of Screening Visit and/or planned ongoingusage during the study) of psychotropic drugs and/or non-psychotropic drugs ormedication which may affect use of the Senseye DT:

• Narcotics/opioids (e.g., Heroin, Vicodin, oxycodone, codeine, Tramadol, etc.).

• Tricyclic antidepressants (TCAs) (e.g., Tofranil, Pamelor, amitriptyline,doxeprin, etc.).

• Monoamine Oxidase Inhibitors (MAOIs) (e.g., Emsam, Parnate, Nardil, Marplan,etc.).

• Select antihypertensive medications (alpha-2 receptor agonists, clonidine,peripheral adrenergic inhibitors, Alpha & Beta blockers, and Rauwolfiaalkaloids). Note: If Prazosin can be abstained from for > 24 hours prior to theSenseye DT visit, the exclusion does not apply for that medication. Stimulants (e.g., Amphetamines, Ritalin, Focalin, pseudoephedrine/Sudafed, ecstasy,cocaine, methamphetamines, cathinones, etc.). Note: Caffeine or nicotine use is notexclusionary. Note: that if Sudafed, pseudoephedrine, and stimulants commonly usedto treat ADHD (e.g., Ritalin, Focalin, Adderall, etc. can be abstained from for > 24hours prior to the Senseye DT visit, the exclusion does not apply for thosemedications.

• Psychedelics/psychotomimetics (Lysergic acid, psilocybin, mescaline,phencyclidine, methoxetamine, etc.).

• Cholinergic or anticholinergic agents (e.g., Urecholine, Pilocar, Aricept,Miostat, Evoxac, ipratropium/Atrovent, oxybutynin/Ditropan, scopolamine, etc.),except antihistamines other than Benadryl or diphenhydramine. Note: IfBenadryl/diphenhydramine can be abstained from for > 24 hours prior to theSenseye DT visit, the exclusion does not apply.

• Spravato or Ketamine.

• Eye drops unless the participant is able to abstain from use for > 72 hoursprior to the Senseye DT visit. Note: Artificial tears can be used if neededduring the Senseye DT use.

• Central Nervous System (CNS) depressants (Benzodiazepines and Barbiturates)

10. Current reported usage (within 2 weeks of Screening Visit and/or planned ongoingusage during the study) of vagal nerve stimulation, deep brain stimulation,transcranial magnetic stimulation, or other stimulation or energy-based therapies.

11. Any condition which precludes the ability for patients to safely and accuratelycomplete clinical assessments, questionnaires, or to follow instructions necessaryto administer the Senseye DT (e.g., significant developmental disabilities, languagedisorders, cognitive deficiencies, or other neurodevelopmental disorders).

12. Medical diagnosis of Traumatic Brain Injury (TBI) within the last 12 months based onparticipant self-report.

13. Lifetime history of any of the following: surgical procedures involving the brain ormeninges, encephalitis, meningitis, degenerative central nervous system (CNS)disorder (e.g., Alzheimer's Disease, Parkinson's Disease), or any otherdisease/procedure/accident/intervention that, according to the clinician, is deemedassociated with significant injury to, or malfunction of, the CNS.

14. Involved in active litigation related to the participant's psychiatric symptoms

15. Pregnancy as determined by self-report.

16. Currently incarcerated.

17. Participant requires a legal authorized representative to consent.

18. Prior enrollment in this study or in other Senseye Machine Learning (ML) studieswithin the last 12 months.

19. Unwilling or unable to comply with all study related procedures, in the opinion ofthe investigator, including medical and non-medical procedures.