Heart Rate Variability and Stress Management Enhancement

NCT04381182 | Terminated

• 1 other identifier: STUDY19020291
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Heart Rate Variability

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Biostrap/Apollo Device Use

OTHER

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

Interventions

Apollo Wearable Device DEVICE

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

Biostrap/Apollo Device Use

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurosurgical Resident (UPMC)

You may not qualify if:

• None

Sponsors & Collaborators

• Joseph Maroon: lead
• Apollo Neuro: collaborator

Study Sites (1)

UPMC Presbyterian Hospital Department of Neurological Surgery

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Joseph Maroon

  Department of Neurological Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: September 1, 2021
• Primary Completion: July 20, 2022
• Study Completion: August 20, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available at one month from study start and will be available for two months from study start.
• Access Criteria: Principal investigator and three additional primary study members will have access to data.

Locations

US (1)