Heart Rate Variability and Stress Management Enhancement

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

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.

Study Overview

• Status: Terminated
• Conditions: Stress; Heart Rate Variability
• Intervention / Treatment: Device: Apollo Wearable Device

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian Hospital Department of Neurological Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Neurosurgical Resident (UPMC)

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to two month heart rate variability	Quantitative (average range, beats per minute)	Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
Change from baseline to two month Perceived Stress Scale	Questionnaire, 14 point form/scale ranging from 0-50 with higher scores signifiying increased stress	Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
Change from baseline to two month Quick Inventory of Depressive Symptomatology (QIDS)	Questionnaire ranging from 0-27 and measuring major depressive symptomatology. Higher scores signify more severe depression.	Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point

Collaborators and Investigators

• Sponsor: Joseph Maroon
• Collaborators: Apollo Neuro
• Investigators: Principal Investigator: Joseph Maroon, Department of Neurological Surgery

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): August 20, 2022

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STUDY19020291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified changes in heart rate variability, de-identified changes between QIDS and PSS questionnaires.
• IPD Sharing Time Frame: Data will be available at one month from study start and will be available for two months from study start.
• IPD Sharing Access Criteria: Principal investigator and three additional primary study members will have access to data.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No