Validation of a Wearable Sensor for Stress Response in a Virtual Reality Environment
1 other identifier
observational
53
1 country
1
Brief Summary
Monitor stress response in a virtual reality environment using a wearable sensor to analyze and track heart rate variability (HRV).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 9, 2014
CompletedFirst Posted
Study publicly available on registry
December 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 20, 2015
May 1, 2015
4 months
December 9, 2014
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Collect continuous physiological data in real-time from participants undergoing a set of standardized stress exposure experiences.
~Four hours
Eligibility Criteria
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.
You may qualify if:
- Adults over age 18
You may not qualify if:
- History of seizures
- History of vertigo or other vestibular abnormalities
- History of a chronic anxiety disorder
- History of cardiovascular disease or heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virtual Reality Medical Center
San Diego, California, 92121, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Steinhubl, MD
STSI
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 9, 2014
First Posted
December 22, 2014
Study Start
November 1, 2014
Primary Completion
March 1, 2015
Study Completion
May 1, 2015
Last Updated
May 20, 2015
Record last verified: 2015-05