Heart Rate Variability and Stress Management Enhancement

Overview

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.

Full Title of Study: “Impact of Heart Rate Variability Modulation on Stress and Performance Among Neurosurgical Residents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 20, 2022

Interventions

  • Device: Apollo Wearable Device
    • Participants wear Apollo device which generates vibration frequencies on skin and can be controlled by the user

Arms, Groups and Cohorts

  • Other: Biostrap/Apollo Device Use
    • Participants wear a Biostrap wearable device which measures steps, heart rate, heart rate variability, sleep metrics, and quantitative data in typical day-to-day activities of residents. Participants then again wear Biostrap except now also with the Apollo device which is worn around the ankle and is suggested to modulate heart rate variability and perceived stress of participants.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Neurosurgical Resident (UPMC) Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Joseph Maroon
  • Collaborator
    • Apollo Neuro
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Joseph Maroon, Clinical Professor – University of Pittsburgh
  • Overall Official(s)
    • Joseph Maroon, Principal Investigator, Department of Neurological Surgery

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