Biochemical and Physiological Response to Stressogenic Stimuli

• Sponsor: Nadav Goldental (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04076215
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Behavioral: Stressogenic stimulus; Device: Biobeat smart watch and adhesive biosensor patches.	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli
• Anticipated Study Start Date: Sep 1, 2019
• Anticipated Primary Completion Date: Feb 1, 2020
• Anticipated Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pariticapnts with PTSD	Behavioral: Stressogenic stimulus; Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting; Device: Biobeat smart watch and adhesive biosensor patches.; Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.
Experimental: Pariticapnts without PTSD (controls)	Behavioral: Stressogenic stimulus; Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting; Device: Biobeat smart watch and adhesive biosensor patches.; Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.

Outcome Measures

Primary Outcome Measures

1. Significant differences between groups - HRV [3 hours]

   Significant differences in Heart Rate Variability - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

2. Significant differences in physiological changes between groups - temperature [3 hours]

   Significant differences in physiological changes - body temperature- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

3. Significant differences in physiological changes between groups - SPO2 [3 hours]

   Significant differences in physiological changes - Saturation SPO2- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

4. Significant differences in physiological changes between groups - blood pressure [3 hours]

   Significant differences in physiological changes - continuous blood pressure- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

5. Significant differences in physiological changes between groups - pulse pressure [3 hours]

   Significant differences in physiological changes - pulse pressure - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

6. Significant differences in physiological changes between groups -respiratory rate [3 hours]

   Significant differences in physiological changes - respiratory rate- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

7. Significant differences in physiological changes between groups -stroke volume [3 hours]

   Significant differences in physiological changes - stroke volume- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

8. Significant differences in physiological changes between groups -cardiac output [3 hours]

   Significant differences in physiological changes - cardiac output - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

9. Significant differences in physiological changes between groups - systemic vascular resistance [3 hours]

   Significant differences in physiological changes - systemic vascular resistance- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

10. Significant differences in cortisol levels between groups [3 hours]

    Significant differences in biochemical changes - cortisol - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

11. Significant differences in biochemical changes between groups - C-reactive protein [3 hours]

    Significant differences in biochemical changes - C-reactive protein - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

12. Significant differences in biochemical changes between groups - Interleukin 6 [3 hours]

    Significant differences in biochemical changes - Interleukin 6 - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

13. Significant differences in biochemical changes between groups - N-terminal B-type natriuretic peptide [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

14. Significant differences in biochemical changes between groups - 8-oxo-7 [3 hours]

    Significant differences in biochemical changes - 8-oxo-7- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

15. Significant differences in biochemical changes between groups - 8-dihydro-2'-deoxyguanosine [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

16. Significant differences in biochemical changes between groups - hexanone [3 hours]

    Significant differences in biochemical changes - hexanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

17. Significant differences in biochemical changes between groups - acetic acid [3 hours]

    Significant differences in biochemical changes - acetic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

18. Significant differences in biochemical changes between groups - heptane [3 hours]

    Significant differences in biochemical changes - heptane - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

19. Significant differences in biochemical changes between groups - hexanal [3 hours]

    Significant differences in biochemical changes -hexanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

20. Significant differences in biochemical changes between groups - 3-heptanone [3 hours]

    Significant differences in biochemical changes - 3-heptanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

21. Significant differences in biochemical changes between groups - hexanoic acid [3 hours]

    Significant differences in biochemical changes - hexanoic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

22. Significant differences in biochemical changes between groups - heptanal [3 hours]

    Significant differences in biochemical changes -heptanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

23. Significant differences in biochemical changes between groups - nonanal [3 hours]

    Significant differences in biochemical changes - nonanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

24. Significant differences in biochemical changes between groups - glucose [3 hours]

    Significant differences in biochemical changes - glucose - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nadav Goldental

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nadav Goldental, Principal investigator, The Chaim Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT04076215
• Other Study ID Numbers: 6263-19-SMC
• First Posted: Sep 3, 2019
• Last Update Posted: Sep 3, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Sep 3, 2019