Heart Rate Variability and Stress Management Enhancement

Sponsor

Joseph Maroon (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04381182

Collaborator

Apollo Neuro (Other)

Enrollment

Location

Arm

11.6

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Heart Rate Variability	Device: Apollo Wearable Device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jul 20, 2022

Anticipated Study Completion Date :

Aug 20, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline to two month heart rate variability [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 [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Neurosurgical Resident (UPMC)

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Presbyterian Hospital Department of Neurological Surgery	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

Joseph Maroon
Apollo Neuro

Investigators

Principal Investigator: Joseph Maroon, Department of Neurological Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joseph Maroon, Clinical Professor, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT04381182

Other Study ID Numbers:

STUDY19020291

First Posted:

May 8, 2020

Last Update Posted:

Sep 10, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 10, 2021