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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04381182
Other study ID # STUDY19020291
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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