Burnout, ProfessionalNCT05731856
Impact of Heart Rate Variability Modulation on Stress Management Among Physicians
A study testing Apollo Wearable in people with Burnout, Professional, run by Michelle Thompson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional
- What is being tested?
- Apollo Wearable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- UPMC attending physicians and residents. The participants must have either IOS or Android phones.
Who cannot join
- Unwillingness or inability to participate in the study
- Currently own an Apollo device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Franchesca Inay, BS, Inay.Franchesca@medstudent.pitt.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Burnout, Professional
- Being tested
- Apollo Wearable
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo WearableDevice
Also called Apollo Neuro
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Apollo Wearable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Through study completion, on average 8 weeks
Secondary outcomes (2)
The Quick Inventory of Depressive Symptomatology
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.
Measured: Through study completion, on average 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Through study completion, on average 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Jan 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michelle Thompson
- Sponsor type
- University, hospital or other
- Collaborators
- The Board of Medicine, Apollo Neuroscience, Inc.
- Responsible party
- Sponsor-investigator, Michelle Thompson, University of Pittsburgh
- Investigators
- Michelle Thompson, DO, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731856
- Sponsor's protocol ID
- STUDY22060130
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Heart Rate Variability Modulation on Stress and Recovery Among Physicians
- ClinicalTrials.gov ID
- NCT05731856
- Acronym / sponsor ID
- STUDY22060130
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Michelle ThompsonUniversity, hospital or other
- Collaborators
- The Board of Medicine, Apollo Neuroscience, Inc.
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
| Arm | Type | Receives |
|---|---|---|
| Apollo Intervention Arm | Experimental | Device: Apollo WearableEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- UPMC attending physicians and residents. The participants must have either IOS or Android phones.
Key exclusion criteria (2 listed)
- Unwillingness or inability to participate in the study
- Currently own an Apollo device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apollo WearableAlso: Apollo NeuroParticipants 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. | Device | Apollo Intervention Arm |
Primary outcome
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
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.
2 secondary outcomes
The Quick Inventory of Depressive Symptomatology
Time frame: Through study completion, on average 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Through study completion, on average 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Thompson, DO principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo Wearable in people with Burnout, Professional, run by Michelle Thompson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franchesca Inay, BS (5512234990, inay.franchesca@medstudent.pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Copenhagen Burnout Inventory (time frame: Through study completion, on average 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.