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Biochemical and Physiological Response to Stressogenic Stimuli

N

Nadav Goldental

Status

Unknown

Conditions

Post Traumatic Stress Disorder

Treatments

Behavioral: Stressogenic stimulus
Device: Biobeat smart watch and adhesive biosensor patches.

Study type

Interventional

Funder types

Other

Identifiers

NCT04076215
6263-19-SMC

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Pariticapnts with PTSD
Experimental group
Treatment:
Behavioral: Stressogenic stimulus
Device: Biobeat smart watch and adhesive biosensor patches.
Pariticapnts without PTSD (controls)
Experimental group
Treatment:
Behavioral: Stressogenic stimulus
Device: Biobeat smart watch and adhesive biosensor patches.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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