Biochemical and Physiological Response to Stressogenic Stimuli

Nadav Goldental

Status: Unknown

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: Stressogenic stimulus; Device: Biobeat smart watch and adhesive biosensor patches.

Study type: Interventional

Funder types: Other

Identifiers

NCT04076215

6263-19-SMC

Details and patient eligibility

About

Post-traumatic stress disorder (PTSD) is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. A psychiatric diagnosis of PTSD is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. Discernable patterns of stress-related measures may constitute a physiological and biochemical phenotype characteristic of PTSD, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans.

The current study is aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with PTSD. Physiological and biochemical data will be collected from participants with and without PTSD using wearable sensors and adhesive biosensor patches. The data will be collected in two conditions: in a neutral, quiet situation, and during and following exposure to controlled stressogenic stimuli.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• PTSD diagnosis (excluding controls)
• Proper ability to give informed consent

Exclusion criteria

• Active oncological/cardiovascular condition
• Dialysis patients
• Active psychotic or suicidal symptoms
• Severe dissociative symptoms
• A traumatic brain injury (TBI) diagnosis
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Pariticapnts with PTSD

Experimental group

Treatment:

Behavioral: Stressogenic stimulus

Device: Biobeat smart watch and adhesive biosensor patches.

Pariticapnts without PTSD (controls)

Experimental group

Treatment:

Behavioral: Stressogenic stimulus

Device: Biobeat smart watch and adhesive biosensor patches.