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Heart Rate Variability and Stress Management Enhancement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381182
Recruitment Status : Active, not recruiting
First Posted : May 8, 2020
Last Update Posted : September 10, 2021
Sponsor:
Collaborator:
Apollo Neuro
Information provided by (Responsible Party):
Joseph Maroon, University of Pittsburgh

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2021
Estimated Primary Completion Date : July 20, 2022
Estimated Study Completion Date : August 20, 2022

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from baseline to two month heart rate variability [ Time Frame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point ]
    Quantitative (average range, beats per minute)

  2. Change from baseline to two month Perceived Stress Scale [ Time Frame: 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

  3. Change from baseline to two month Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Neurosurgical Resident (UPMC)

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381182


Locations
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United States, Pennsylvania
UPMC Presbyterian Hospital Department of Neurological Surgery
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Joseph Maroon
Apollo Neuro
Investigators
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Principal Investigator: Joseph Maroon Department of Neurological Surgery
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Responsible Party: Joseph Maroon, Clinical Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04381182    
Other Study ID Numbers: STUDY19020291
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified changes in heart rate variability, de-identified changes between QIDS and PSS questionnaires.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No