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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
Nadav Goldental
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 22, 2019
    Last Updated
    August 29, 2019
    Sponsor
    Nadav Goldental
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    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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