Biochemical and Physiological Response to Stressogenic Stimuli
Primary Purpose
Post Traumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stressogenic stimulus
Biobeat smart watch and adhesive biosensor patches.
Sponsored by
About this trial
This is an interventional diagnostic trial for Post Traumatic Stress Disorder
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pariticapnts with PTSD
Pariticapnts without PTSD (controls)
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04076215
Brief Title
Biochemical and Physiological Response to Stressogenic Stimuli
Official Title
Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nadav Goldental
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pariticapnts with PTSD
Arm Type
Experimental
Arm Title
Pariticapnts without PTSD (controls)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Stressogenic stimulus
Intervention Description
Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting
Intervention Type
Device
Intervention Name(s)
Biobeat smart watch and adhesive biosensor patches.
Intervention Description
Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.
Primary Outcome Measure Information:
Title
Significant differences between groups - HRV
Description
Significant differences in Heart Rate Variability - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in physiological changes between groups - temperature
Description
Significant differences in physiological changes - body temperature- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in physiological changes between groups - SPO2
Description
Significant differences in physiological changes - Saturation SPO2- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in physiological changes between groups - blood pressure
Description
Significant differences in physiological changes - continuous blood pressure- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in physiological changes between groups - pulse pressure
Description
Significant differences in physiological changes - pulse pressure - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in physiological changes between groups -respiratory rate
Description
Significant differences in physiological changes - respiratory rate- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in physiological changes between groups -stroke volume
Description
Significant differences in physiological changes - stroke volume- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in physiological changes between groups -cardiac output
Description
Significant differences in physiological changes - cardiac output - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in physiological changes between groups - systemic vascular resistance
Description
Significant differences in physiological changes - systemic vascular resistance- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in cortisol levels between groups
Description
Significant differences in biochemical changes - cortisol - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - C-reactive protein
Description
Significant differences in biochemical changes - C-reactive protein - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - Interleukin 6
Description
Significant differences in biochemical changes - Interleukin 6 - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - N-terminal B-type natriuretic peptide
Description
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
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - 8-oxo-7
Description
Significant differences in biochemical changes - 8-oxo-7- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - 8-dihydro-2'-deoxyguanosine
Description
Significant differences in biochemical changes - 8-dihydro-2'-deoxyguanosine - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - hexanone
Description
Significant differences in biochemical changes - hexanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - acetic acid
Description
Significant differences in biochemical changes - acetic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - heptane
Description
Significant differences in biochemical changes - heptane - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - hexanal
Description
Significant differences in biochemical changes -hexanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - 3-heptanone
Description
Significant differences in biochemical changes - 3-heptanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - hexanoic acid
Description
Significant differences in biochemical changes - hexanoic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - heptanal
Description
Significant differences in biochemical changes -heptanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - nonanal
Description
Significant differences in biochemical changes - nonanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
Title
Significant differences in biochemical changes between groups - glucose
Description
Significant differences in biochemical changes - glucose - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Biochemical and Physiological Response to Stressogenic Stimuli
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