Working… Menu
Trial record 2 of 7 for:    steinhubl

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02321774
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : May 20, 2015
Information provided by (Responsible Party):
Steven Steinhubl, Scripps Translational Science Institute

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

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.

Layout table for study information
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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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.

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

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 identifier (NCT number): NCT02321774

Layout table for location information
United States, California
Virtual Reality Medical Center
San Diego, California, United States, 92121
Sponsors and Collaborators
Scripps Translational Science Institute
Layout table for investigator information
Principal Investigator: Steven Steinhubl, MD STSI
Layout table for additonal information
Responsible Party: Steven Steinhubl, Principal Investigator, Scripps Translational Science Institute 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:
Virtual Reality
Wearable Sensor