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Clinical Trials/NCT04076215
NCT04076215
Unknown
Not Applicable

Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli

Nadav Goldental0 sites50 target enrollmentSeptember 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
Nadav Goldental
Enrollment
50
Primary Endpoint
Significant differences between groups - HRV
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2019
End Date
June 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Nadav Goldental

Principal investigator

The Chaim Sheba Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Significant differences between groups - HRV

Time Frame: 3 hours

Significant differences in Heart Rate Variability - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in physiological changes between groups - temperature

Time Frame: 3 hours

Significant differences in physiological changes - body temperature- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in physiological changes between groups - SPO2

Time Frame: 3 hours

Significant differences in physiological changes - Saturation SPO2- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in physiological changes between groups - blood pressure

Time Frame: 3 hours

Significant differences in physiological changes - continuous blood pressure- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in physiological changes between groups - pulse pressure

Time Frame: 3 hours

Significant differences in physiological changes - pulse pressure - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in physiological changes between groups -respiratory rate

Time Frame: 3 hours

Significant differences in physiological changes - respiratory rate- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in physiological changes between groups -stroke volume

Time Frame: 3 hours

Significant differences in physiological changes - stroke volume- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in physiological changes between groups -cardiac output

Time Frame: 3 hours

Significant differences in physiological changes - cardiac output - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in physiological changes between groups - systemic vascular resistance

Time Frame: 3 hours

Significant differences in physiological changes - systemic vascular resistance- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in cortisol levels between groups

Time Frame: 3 hours

Significant differences in biochemical changes - cortisol - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - C-reactive protein

Time Frame: 3 hours

Significant differences in biochemical changes - C-reactive protein - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - Interleukin 6

Time Frame: 3 hours

Significant differences in biochemical changes - Interleukin 6 - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - N-terminal B-type natriuretic peptide

Time Frame: 3 hours

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

Significant differences in biochemical changes between groups - 8-oxo-7

Time Frame: 3 hours

Significant differences in biochemical changes - 8-oxo-7- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - 8-dihydro-2'-deoxyguanosine

Time Frame: 3 hours

Significant differences in biochemical changes - 8-dihydro-2'-deoxyguanosine - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - hexanone

Time Frame: 3 hours

Significant differences in biochemical changes - hexanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - acetic acid

Time Frame: 3 hours

Significant differences in biochemical changes - acetic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - heptane

Time Frame: 3 hours

Significant differences in biochemical changes - heptane - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - hexanal

Time Frame: 3 hours

Significant differences in biochemical changes -hexanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - 3-heptanone

Time Frame: 3 hours

Significant differences in biochemical changes - 3-heptanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - hexanoic acid

Time Frame: 3 hours

Significant differences in biochemical changes - hexanoic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - heptanal

Time Frame: 3 hours

Significant differences in biochemical changes -heptanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - nonanal

Time Frame: 3 hours

Significant differences in biochemical changes - nonanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Significant differences in biochemical changes between groups - glucose

Time Frame: 3 hours

Significant differences in biochemical changes - glucose - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

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