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Heart Rate Variability and Stress Management Enhancement

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04381182
Enrollment
20
Registered
2020-05-08
Start date
2021-09-01
Completion date
2022-08-20
Last updated
2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rate Variability, Stress

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.

Interventions

DEVICEApollo Wearable Device

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

Sponsors

Apollo Neuro
CollaboratorUNKNOWN
Joseph Maroon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Neurosurgical Resident (UPMC)

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline to two month heart rate variabilityBaseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time pointQuantitative (average range, beats per minute)
Change from baseline to two month Perceived Stress ScaleBaseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time pointQuestionnaire, 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 pointQuestionnaire ranging from 0-27 and measuring major depressive symptomatology. Higher scores signify more severe depression.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026