Impact of Heart Rate Variability Modulation on Stress Management Among Physicians

NCT05731856 | Recruiting FDA Device

• 1 other identifier: STUDY22060130
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burnout, Professional

Outcome Measures

Primary Outcomes (2)

• Copenhagen Burnout Inventory

  The Copenhagen Burnout Inventory (CBI) is a 19-item self reported measure of burnout. It contains three sub-scales measuring personal burnout, work-related burnout, and client-related burnout

  Through study completion, on average 8 weeks

• Perceived Stress Scale (PSS-10)

  The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress using a 10-item survey. It is a measure of the degree to which situations in one's life are appraised as stressful.

  Through study completion, on average 8 weeks

Secondary Outcomes (2)

• The Quick Inventory of Depressive Symptomatology

  Through study completion, on average 8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  Through study completion, on average 8 weeks

Study Arms (1)

Apollo Intervention Arm

EXPERIMENTAL

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.

Device: Apollo Wearable

Interventions

Apollo Wearable 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.

Also known as: Apollo Neuro

Apollo Intervention Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Unwillingness or inability to participate in the study
• Currently own an Apollo device

Sponsors & Collaborators

• Michelle Thompson: lead
• The Board of Medicine: collaborator
• Apollo Neuroscience, Inc.: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Michelle Thompson, DO

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franchesca Inay, BS

CONTACT

5512234990; inay.franchesca@medstudent.pitt.edu

Mahi Mandala, PhD

CONTACT

4129450345; mahi@apolloneuro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty in Department of Family Medicine

Model Details: This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 16, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)