Biochemical and Physiological Response to Stressogenic Stimuli

Study Overview
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Brief Summary
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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.

Official Title
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Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Stressogenic stimulus
* Device: Biobeat smart watch and adhesive biosensor patches.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pariticapnts with PTSD<br> | Behavioral: Stressogenic stimulus<br>* Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting<br>Device: Biobeat smart watch and adhesive biosensor patches.<br>* Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.<br>|
| Experimental: Pariticapnts without PTSD (controls)<br> | Behavioral: Stressogenic stimulus<br>* Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting<br>Device: Biobeat smart watch and adhesive biosensor patches.<br>* Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant differences between groups - HRV | Significant differences in Heart Rate Variability - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in physiological changes between groups - temperature | Significant differences in physiological changes - body temperature- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in physiological changes between groups - SPO2 | Significant differences in physiological changes - Saturation SPO2- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in physiological changes between groups - blood pressure | Significant differences in physiological changes - continuous blood pressure- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in physiological changes between groups - pulse pressure | Significant differences in physiological changes - pulse pressure - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in physiological changes between groups -respiratory rate | Significant differences in physiological changes - respiratory rate- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in physiological changes between groups -stroke volume | Significant differences in physiological changes - stroke volume- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in physiological changes between groups -cardiac output | Significant differences in physiological changes - cardiac output - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in physiological changes between groups - systemic vascular resistance | Significant differences in physiological changes - systemic vascular resistance- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in cortisol levels between groups | Significant differences in biochemical changes - cortisol - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - C-reactive protein | Significant differences in biochemical changes - C-reactive protein - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - Interleukin 6 | Significant differences in biochemical changes - Interleukin 6 - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - N-terminal B-type natriuretic peptide | Significant differences in biochemical changes - N-terminal B-type natriuretic peptide - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - 8-oxo-7 | Significant differences in biochemical changes - 8-oxo-7- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - 8-dihydro-2'-deoxyguanosine | Significant differences in biochemical changes - 8-dihydro-2'-deoxyguanosine - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - hexanone | Significant differences in biochemical changes - hexanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - acetic acid | Significant differences in biochemical changes - acetic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - heptane | Significant differences in biochemical changes - heptane - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - hexanal | Significant differences in biochemical changes -hexanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - 3-heptanone | Significant differences in biochemical changes - 3-heptanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - hexanoic acid | Significant differences in biochemical changes - hexanoic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - heptanal | Significant differences in biochemical changes -heptanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - nonanal | Significant differences in biochemical changes - nonanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours | 
| Significant differences in biochemical changes between groups - glucose | Significant differences in biochemical changes - glucose - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli | 3 hours |