Clinical trial NCT04076215: Biochemical and Physiological Response to Stressogenic Stimuli
Official title: Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Significant differences between groups - HRV
timeFrame: 3 hours
measure: Significant differences in physiological changes between groups - temperature
timeFrame: 3 hours
measure: Significant differences in physiological changes between groups - SPO2
timeFrame: 3 hours
measure: Significant differences in physiological changes between groups - blood pressure
timeFrame: 3 hours
measure: Significant differences in physiological changes between groups - pulse pressure
timeFrame: 3 hours
measure: Significant differences in physiological changes between groups -respiratory rate
timeFrame: 3 hours
measure: Significant differences in physiological changes between groups -stroke volume
timeFrame: 3 hours
measure: Significant differences in physiological changes between groups -cardiac output
timeFrame: 3 hours
measure: Significant differences in physiological changes between groups - systemic vascular resistance
timeFrame: 3 hours
measure: Significant differences in cortisol levels between groups
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - C-reactive protein
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - Interleukin 6
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - N-terminal B-type natriuretic peptide
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - 8-oxo-7
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - 8-dihydro-2'-deoxyguanosine
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - hexanone
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - acetic acid
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - heptane
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - hexanal
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - 3-heptanone
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - hexanoic acid
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - heptanal
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - nonanal
timeFrame: 3 hours
measure: Significant differences in biochemical changes between groups - glucose
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
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