Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Nadav Goldental
- Enrollment
- 50
- Primary Endpoint
- Significant differences between groups - HRV
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Pariticapnts with PTSD
Intervention: Stressogenic stimulus (Behavioral)
Pariticapnts with PTSD
Intervention: Biobeat smart watch and adhesive biosensor patches. (Device)
Pariticapnts without PTSD (controls)
Intervention: Stressogenic stimulus (Behavioral)
Pariticapnts without PTSD (controls)
Intervention: Biobeat smart watch and adhesive biosensor patches. (Device)
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Nadav Goldental
Principal investigator
The Chaim Sheba Medical Center