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Biochemical and Physiological Response to Stressogenic Stimuli

Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04076215
Enrollment
50
Registered
2019-09-03
Start date
2019-09-30
Completion date
2020-06-30
Last updated
2019-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

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.

Interventions

BEHAVIORALStressogenic stimulus

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

DEVICEBiobeat smart watch and adhesive biosensor patches.

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

Sponsors

Nadav Goldental
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Significant differences in biochemical changes between groups - N-terminal B-type natriuretic peptide3 hoursSignificant 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-73 hoursSignificant 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'-deoxyguanosine3 hoursSignificant differences in biochemical changes - 8-dihydro-2'-deoxyguanosine - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences between groups - HRV3 hoursSignificant 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 - temperature3 hoursSignificant 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 - SPO23 hoursSignificant 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 pressure3 hoursSignificant 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 pressure3 hoursSignificant 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 rate3 hoursSignificant 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 volume3 hoursSignificant 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 output3 hoursSignificant 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 resistance3 hoursSignificant 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 groups3 hoursSignificant 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 protein3 hoursSignificant 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 63 hoursSignificant 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 - hexanone3 hoursSignificant 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 acid3 hoursSignificant 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 - heptane3 hoursSignificant 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 - hexanal3 hoursSignificant 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-heptanone3 hoursSignificant 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 acid3 hoursSignificant 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 - heptanal3 hoursSignificant 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 - nonanal3 hoursSignificant 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 - glucose3 hoursSignificant differences in biochemical changes - glucose - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026