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

Sponsor
Scripps Translational Science Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02321774
Collaborator
(none)
53
Enrollment
1
Location
5.9
Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    53 participants
    Time Perspective:
    Prospective
    Official Title:
    Validation of a Wearable Sensor for Stress Response in a Virtual Reality Environment
    Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Mar 1, 2015
    Actual Study Completion Date :
    May 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Changes in heart rate variability (HRV) as detected by the wristband sensor relative to measures of stress noted by lab-based physiologic monitoring equipment. [~Four hours]

      Collect continuous physiological data in real-time from participants undergoing a set of standardized stress exposure experiences.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virtual Reality Medical Center San Diego California United States 92121

    Sponsors and Collaborators

    • Scripps Translational Science Institute

    Investigators

    • Principal Investigator: Steven Steinhubl, MD, STSI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Steven Steinhubl, Principal Investigator, Scripps Translational Science Institute
    ClinicalTrials.gov Identifier:
    NCT02321774
    Other Study ID Numbers:
    • IRB-14-6485
    First Posted:
    Dec 22, 2014
    Last Update Posted:
    May 20, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Steven Steinhubl, Principal Investigator, Scripps Translational Science Institute
    Stress
    Virtual Reality
    Wearable Sensor
    Wellness

    Study Results

    No Results Posted as of May 20, 2015