Impact of Heart Rate Variability Modulation on Stress Management Among Physicians

NCT ID: NCT05731856

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2025-11-30

Brief Summary

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The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects burnout in physicians.

Detailed Description

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This study will be conducted by using a Tuned Vibroacoustic Stimulation (TVS) device(the commercially available TVS device known as the Apollo wearable), that has been shown in clinical studies at University of Pittsburgh to improve heart rate variability and recovery under stress. The Apollo wearable generates low volume sound waves that feel like a soothing touch to the skin. This study will assess whether slight modulation of heart rate variability (HRV) will result in a reduction in stress, improved recovery, and recovery in and around the hospital. Physicians will wear the Apollo device for heart rate variability modulation and complete questionnaires before and after use of the Apollo device for comparison of outcomes.

Conditions

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Burnout, Professional

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Apollo Intervention Arm

Eligible UPMC Physicians and Residents who consent to be part of this study will use an Apollo Device TVS (10-200 Hz) attached to the subject's wrist or ankle via a commercially available wearable vibration technology that can deliver TVS (Transcutaneous Vibratory Stimulation). The intensity will be targeted for the sensory threshold (the level at which the vibration is just noticeable), as this is where the TVS seems most effective from prior studies. Similar vibratory stimuli have been demonstrated to be safe in the literature. The intensity of the vibration will be adjusted to the subjects' comfort and can be controlled by the subject at any time.

Group Type EXPERIMENTAL

Apollo Wearable

Intervention Type DEVICE

Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phones. Participants will use the Apollo for at least 30 minutes after waking up and at least 30 minutes before bed on the corresponding settings for those times of the day. They will be given the Apollo Device TVS (10-200 Hz) to borrow, which they will be instructed to wear daily. They will be asked to wear the device until all study data is collected.

Interventions

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Apollo Wearable

Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phones. Participants will use the Apollo for at least 30 minutes after waking up and at least 30 minutes before bed on the corresponding settings for those times of the day. They will be given the Apollo Device TVS (10-200 Hz) to borrow, which they will be instructed to wear daily. They will be asked to wear the device until all study data is collected.

Intervention Type DEVICE

Other Intervention Names

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Apollo Neuro

Eligibility Criteria

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Inclusion Criteria

* UPMC attending physicians and residents. The participants must have either IOS or Android phones.

Exclusion Criteria

* Unwillingness or inability to participate in the study
* Currently own an Apollo device
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Board of Medicine

OTHER

Sponsor Role collaborator

Apollo Neuroscience, Inc.

INDUSTRY

Sponsor Role collaborator

Michelle Thompson

OTHER

Sponsor Role lead

Responsible Party

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Michelle Thompson

Faculty in Department of Family Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michelle Thompson, DO

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY22060130

Identifier Type: -

Identifier Source: org_study_id

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