Validation of a Wearable Sensor for Stress Response in a Virtual Reality Environment

NCT ID: NCT02321774

Last Updated: 2015-05-20

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

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

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Monitor stress response in a virtual reality environment using a wearable sensor to analyze and track heart rate variability (HRV).

Detailed Description

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Wearable sensor technology is being developed that may allow, for the first time, the ability for individuals to better recognized their level of stress in any given situation on a continuous basis. A major focus of many of these wearable sensors is being able to accurately analyze and track heart rate variability (HRV), which is indicative of primarily parasympathetic/vagal tone and emotional state.3 However there is a need to validate the reliability of this measured response and understand any inter-individual variability.

The present study will take advantage of virtual reality scenarios to expose healthy volunteers to controlled stressful situations during monitoring with several standardized lab-based non-invasive physiological sensors as well as a novel wrist band sensor device to track individual response to stress.

Conditions

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Healthy

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adults over age 18

Exclusion Criteria

* History of seizures
* History of vertigo or other vestibular abnormalities
* History of a chronic anxiety disorder
* History of cardiovascular disease or heart disease
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scripps Translational Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Steven Steinhubl

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Steinhubl, MD

Role: PRINCIPAL_INVESTIGATOR

STSI

Locations

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Virtual Reality Medical Center

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-14-6485

Identifier Type: -

Identifier Source: org_study_id

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