- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05731856
Impact of Heart Rate Variability Modulation on Stress Management Among Physicians
February 16, 2026 updated by: Michelle Thompson
Impact of Heart Rate Variability Modulation on Stress and Recovery Among Physicians
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Franchesca Inay, BS
- Phone Number: 5512234990
- Email: inay.franchesca@medstudent.pitt.edu
Study Contact Backup
- Name: Mahi Mandala, PhD
- Phone Number: 4129450345
- Email: mahi@apolloneuro.com
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- Recruiting
- University of Pittsburgh
-
Contact:
- Franchesca Inay, BS
- Email: Inay.Franchesca@medstudent.pitt.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Copenhagen Burnout Inventory
Time Frame: Through study completion, on average 8 weeks
|
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)
Time Frame: Through study completion, on average 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Quick Inventory of Depressive Symptomatology
Time Frame: Through study completion, on average 8 weeks
|
The QIDS is a brief, 16-item self-rated assessment tool used to evaluate the symptoms of depression present in a patient during the past week.
|
Through study completion, on average 8 weeks
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Through study completion, on average 8 weeks
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
With a range of scores 1-21.
|
Through study completion, on average 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michelle Thompson, DO, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2024
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Study Registration Dates
First Submitted
February 9, 2023
First Submitted That Met QC Criteria
February 9, 2023
First Posted (Actual)
February 16, 2023
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 16, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY22060130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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