Biochemical and Physiological Response to Stressogenic Stimuli

Post Traumatic Stress Disorder Clinical Trial

Official title:

Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04076215
• Other study ID #: 6263-19-SMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: June 2020

Study information

• Verified date: August 2019
• Source: The Chaim Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nadav Goldental

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours
Primary	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	3 hours