Heart Rate Variability and Stress Management Enhancement

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04381182
• Other study ID #: STUDY19020291
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: August 20, 2022

Study information

• Verified date: December 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Neurosurgical Resident (UPMC)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Heart Rate Variability
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	UPMC Presbyterian Hospital Department of Neurological Surgery	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Joseph Maroon	Apollo Neuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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