Heart Rate Variability and Stress Management Enhancement

Not Applicable

Terminated

• Conditions: Heart Rate Variability; Stress
• Interventions: Device: Apollo Wearable Device

• Registration Number: NCT04381182
• Lead Sponsor: Joseph Maroon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Study Start: 2021-09-01
• Primary Completion: 2022-07-20
• Study Completion: 2022-08-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Neurosurgical Resident (UPMC)

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biostrap/Apollo Device Use	Apollo Wearable Device	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UPMC Presbyterian Hospital Department of Neurological Surgery; 🇺🇸 Pittsburgh, Pennsylvania, United States