BurnoutPhase 4Voice-BNCT07780812
Evaluation of Speech and Voice Biomarkers in Association With Burnout
A Phase 4 study testing Calmigo in people with Burnout and Burnout, Healthcare Workers, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
This project aims to explore how speech patterns and voice characteristics can be used to detect signs of burnout and stress in physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Burnout, Healthcare Workers
- What is being tested?
- Calmigo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 2 Oct 2027
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Aim 1 Inclusion Criteria:
- Adult individuals (18 years-old or older)
- Healthcare workers (physicians, nurses, advanced practice providers, and other clinical staff) at the Minneapolis Heart Institute
- Ability to use the CalmiGo device for 12-weeks
- Willingness to complete study questionnaires, have speech and voice samples recorded and analyzed at the beginning of the study.
AIM 2 Inclusion criteria
- Adult individuals (18 years-old or older)
- Healthcare workers (physicians, nurses, advanced practice providers, and other clinical staff) with burnout (Mini-Z 2.0 single item burnout score 3, 4 or 5 on 5 choice item, question 2).
- Ability to use the CalmiGo device for 12-weeks
- Willingness to complete study questionnaires, have speech and voice samples recorded and analyzed at the beginning and end of the study.
AIM 1 and 2Exclusion Criteria:
- English is not their preferred language
- Current or known history of a voice or speech disorder
- Current or history of laryngeal malignancy
- History of laryngeal surgery
- Known diagnosis of a voice disorder: Vocal Cord Nodules, Polyp, or Cyst; Vocal Cord Paralysis; Dysphonia
- Laryngitis
- Dyslexia
- Muscle Tension
- Aphasia
- Stuttering
- Dysarthria
- Essential Tremor
- Neurodegenerative conditions (Parkinson's Disease, Multiple Sclerosis, ALS, MSA, Dementia)
- Severe psychiatric disorder (depression, anxiety, bipolar, schizophrenia, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bavana Rangan, BDS, MPH contact
United States1 site, 1 recruiting
- Recruiting
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Michaella Alexandrou, MD, 612-863-4768, michaella.alexandrou@allina.com
About this study
This project aims to explore how speech patterns and voice characteristics can be used to detect signs of burnout and stress in physicians.
Read the detailed description
Aim 1: To determine the association amongst acoustic features, derived from speech and voice samples, and burnout and mental stress measured using questionnaires in healthcare workers (physicians, nurses, advanced practice providers, and other clinical staff) at the Minneapolis Heart Institute.
Aim 2: To compare the effects of the CalmiGo stress management device on acoustic features, derived from voice samples, and burnout and mental stress assessed using questionnaires in healthcare workers (physicians, nurses, advanced practice providers, and other clinical staff) with burnout (Mini-Z 2.0 single item burnout score 3, 4 or 5 on 5 choice item, question 2) against no specific guidance.
- Conditions
- Burnout, Burnout, Healthcare Workers
- Being tested
- Calmigo
- Keywords
- voice biomarkers, voice-b, burnout
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalmigoDevice
use of the calmigo device 3 times a day for 3 minutes at a time across 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | Calmigo device Receives: Device: Calmigo |
| No intervention | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Z 2.0 survey score
Burnout as measured by response to the Mini-Z 2.0 survey. A lower score indicates higher burnout
Measured: 12 weeks
Maslach Burnout Inventory (MBI) survey score
Burnout as measured by response to the Maslach Burnout Inventory (MBI) survey. Higher score indicated increased burnout
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start2 Jun 2025
- Primary completion2 Jun 2027 (estimated)
- Study completion2 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Allina Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780812
- Sponsor's protocol ID
- 2297485-5
- Acronym
- Voice-B
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will be assigned a code that is unique to them but does not include information that directly identifies them. This code will be used to share the study information with co-investigators. The groups or individuals who receive the codes information will use it only for the purposes of the research analysis. The voice recordings with the study ID numbers will be uploaded to a secured location.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Speech and Voice Biomarkers in Association With Burnout
- ClinicalTrials.gov ID
- NCT07780812
- Acronym / sponsor ID
- Voice-B / 2297485-5
- Conditions
- Burnout, Burnout, Healthcare Workers
- Keywords
- voice biomarkers, voice-b, burnout
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Collaborators
- Allina Health System
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 2 Oct 2027 (estimated)
- First posted
- 24 Aug 2026 (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.
This project aims to explore how speech patterns and voice characteristics can be used to detect signs of burnout and stress in physicians.
Detailed description
Aim 1: To determine the association amongst acoustic features, derived from speech and voice samples, and burnout and mental stress measured using questionnaires in healthcare workers (physicians, nurses, advanced practice providers, and other clinical staff) at the Minneapolis Heart Institute.
Aim 2: To compare the effects of the CalmiGo stress management device on acoustic features, derived from voice samples, and burnout and mental stress assessed using questionnaires in healthcare workers (physicians, nurses, advanced practice providers, and other clinical staff) with burnout (Mini-Z 2.0 single item burnout score 3, 4 or 5 on 5 choice item, question 2) against no specific guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Device: CalmigoCalmigo device |
| No intervention | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Calmigouse of the calmigo device 3 times a day for 3 minutes at a time across 12 weeks | Device | Intervention Arm |
Primary outcome
Mini-Z 2.0 survey score
Time frame: 12 weeks
Burnout as measured by response to the Mini-Z 2.0 survey. A lower score indicates higher burnout
Maslach Burnout Inventory (MBI) survey score
Time frame: 12 weeks
Burnout as measured by response to the Maslach Burnout Inventory (MBI) survey. Higher score indicated increased burnout
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 24 Aug 2026.
- Individual participant dataSharing planned: Yes. Participants will be assigned a code that is unique to them but does not include information that directly identifies them. This code will be used to share the study information with co-investigators. The groups or individuals who receive the codes information will use it only for the purposes of the research analysis. The voice recordings with the study ID numbers will be uploaded to a secured location.
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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.
Bavana Rangan, BDS, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calmigo in people with Burnout and Burnout, Healthcare Workers, run by Minneapolis Heart Institute Foundation 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?
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 24 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Michaella Alexandrou, MD (612-863-4768, michaella.alexandrou@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Z 2.0 survey score (time frame: 12 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 24 Aug 2026.