Biochemical and Physiological Response to Stressogenic Stimuli

NCT ID: NCT04076215

Last Updated: 2019-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pariticapnts with PTSD

Group Type EXPERIMENTAL

Stressogenic stimulus

Intervention Type BEHAVIORAL

Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting

Biobeat smart watch and adhesive biosensor patches.

Intervention Type DEVICE

Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.

Pariticapnts without PTSD (controls)

Group Type EXPERIMENTAL

Stressogenic stimulus

Intervention Type BEHAVIORAL

Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting

Biobeat smart watch and adhesive biosensor patches.

Intervention Type DEVICE

Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.

Interventions

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Stressogenic stimulus

Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting

Intervention Type BEHAVIORAL

Biobeat smart watch and adhesive biosensor patches.

Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nadav Goldental

OTHER

Sponsor Role lead

Responsible Party

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Nadav Goldental

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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6263-19-SMC

Identifier Type: -

Identifier Source: org_study_id

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