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

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ClinicalTrials.gov Identifier: NCT02321774
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Steven Steinhubl, Scripps Translational Science Institute

Study Description
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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
Healthy

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
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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 : November 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : May 2015
Groups and Cohorts
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Outcome Measures
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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. [ Time Frame: ~Four hours ]
    Collect continuous physiological data in real-time from participants undergoing a set of standardized stress exposure experiences.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will be made up of 50 adult men and women who are in general good health. Individuals will be recruited locally through fliers, word of mouth and email blasts to the Scripps community.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321774


Locations
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United States, California
Virtual Reality Medical Center
San Diego, California, United States, 92121
Sponsors and Collaborators
Scripps Translational Science Institute
Investigators
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Principal Investigator: Steven Steinhubl, MD STSI
More Information
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Responsible Party: Steven Steinhubl, Principal Investigator, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT02321774    
Other Study ID Numbers: IRB-14-6485
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Steven Steinhubl, Scripps Translational Science Institute:
Stress
Virtual Reality
Wearable Sensor
Wellness