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

May 19, 2015 updated by: Steven Steinhubl, Scripps Translational Science Institute
Monitor stress response in a virtual reality environment using a wearable sensor to analyze and track heart rate variability (HRV).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Virtual Reality Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
~Four hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Investigators

  • Principal Investigator: Steven Steinhubl, MD, STSI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-14-6485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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