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Clinical Trials/NCT04381182
NCT04381182
Terminated
Not Applicable

Impact of Heart Rate Variability Modulation on Stress and Performance Among Neurosurgical Residents

Joseph Maroon1 site in 1 country20 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Joseph Maroon
Enrollment
20
Locations
1
Primary Endpoint
Change from baseline to two month heart rate variability
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

This study will be conducted by using two devices (Apollo and Biostrap) for monitoring of baseline physiologic variables and heart rate variability. The biostrap will be worn by residents and will monitor heart rate, heart rate variability, respiratory rate, sleep patterns, steps, etc. The Apollo is a pulse generator device aimed at modulating heart rate variability for (hopefully) reduction in stress and improving performance in and around the hospital. Resident neurosurgeons will wear the biostrap for a two week cycle and follow that with the addition of the Apollo device for heart rate variability modulation.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
August 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Joseph Maroon
Responsible Party
Sponsor Investigator
Principal Investigator

Joseph Maroon

Clinical Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Neurosurgical Resident (UPMC)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline to two month heart rate variability

Time Frame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point

Quantitative (average range, beats per minute)

Change from baseline to two month Perceived Stress Scale

Time Frame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point

Questionnaire, 14 point form/scale ranging from 0-50 with higher scores signifiying increased stress

Change from baseline to two month Quick Inventory of Depressive Symptomatology (QIDS)

Time Frame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point

Questionnaire ranging from 0-27 and measuring major depressive symptomatology. Higher scores signify more severe depression.

Study Sites (1)

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