Biochemical and Physiological Response to Stressogenic Stimuli

Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli

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.

Study Overview

• Status: Unknown
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Stressogenic stimulus; Device: Biobeat smart watch and adhesive biosensor patches.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nadav Goldental

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 6263-19-SMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No