Biochemical and Physiological Response to Stressogenic Stimuli

NCT04076215 | Unknown

• 1 other identifier: 6263-19-SMC
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (24)

• 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

Study Arms (2)

Pariticapnts with PTSD

EXPERIMENTAL

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

Pariticapnts without PTSD (controls)

EXPERIMENTAL

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

Interventions

Stressogenic stimulus BEHAVIORAL

Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting

Pariticapnts with PTSD; Pariticapnts without PTSD (controls)

Biobeat smart watch and adhesive biosensor patches. DEVICE

Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.

Pariticapnts with PTSD; Pariticapnts without PTSD (controls)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nadav Goldental: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 3, 2019
• Study Start: September 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 3, 2019

Record last verified: 2019-08