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RecruitingNCT07780812Voice-BUpdated Aug 24, 2026

Evaluation of Speech and Voice Biomarkers in Association With Burnout

A Phase 4 interventional study of Calmigo in Burnout and Burnout, Healthcare Workers, sponsored by Minneapolis Heart Institute Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Minneapolis Heart Institute Foundation · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2025, registered Aug 2026).
  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Burnout
  • Burnout, Healthcare Workers

Keywords

  • voice biomarkers
  • voice-b
  • burnout
03

In context

Burnout, Psychological

467 studies on the registry are indexed under Burnout, Psychological; 121 are open to participants now.

This study's planned enrollment of 200 is above the median of 80 across 343 interventional studies indexed under Burnout, Psychological.

Browse Burnout, Psychological studies →

Lead sponsor

Minneapolis Heart Institute Foundation is the lead sponsor of 34 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Aim 1 Inclusion Criteria:

  1. Adult individuals (18 years-old or older)
  2. Healthcare workers (physicians, nurses, advanced practice providers, and other clinical staff) at the Minneapolis Heart Institute
  3. Ability to use the CalmiGo device for 12-weeks
  4. Willingness to complete study questionnaires, have speech and voice samples recorded and analyzed at the beginning of the study.

AIM 2 Inclusion criteria

  1. Adult individuals (18 years-old or older)
  2. 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).
  3. Ability to use the CalmiGo device for 12-weeks
  4. 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:

  1. English is not their preferred language
  2. Current or known history of a voice or speech disorder

    1. Current or history of laryngeal
    2. History of laryngeal surgery
    3. Known diagnosis of a voice disorder: Vocal Cord Nodules, Polyp, or Cyst; Vocal Cord Paralysis; Dysphonia
    4. Laryngitis
    5. Dyslexia
    6. Muscle Tension
    7. Aphasia
    8. Stuttering
    9. Dysarthria
    10. Essential Tremor
    11. Neurodegenerative conditions (Parkinson's Disease, Multiple Sclerosis, ALS, MSA, Dementia)
    12. Severe psychiatric disorder (depression, anxiety, bipolar, schizophrenia, etc.)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Intervention Arm

    Calmigo device

    Device: Calmigo

  • No intervention
    No intervention

    no intervention

Interventions

  • DeviceCalmigo

    use of the calmigo device 3 times a day for 3 minutes at a time across 12 weeks

06

What researchers measure

Primary outcomes

  1. Mini-Z 2.0 survey score

    Burnout as measured by response to the Mini-Z 2.0 survey. A lower score indicates higher burnout

    Time frame: 12 weeks

  2. Maslach Burnout Inventory (MBI) survey score

    Burnout as measured by response to the Maslach Burnout Inventory (MBI) survey. Higher score indicated increased burnout

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07780812
Lead sponsor
Minneapolis Heart Institute Foundation
Collaborators
Allina Health
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Jun 2, 2025
Primary completion
Jun 2, 2027 (estimated)
Completion
Oct 2, 2027 (estimated)
Last update
Aug 24, 2026

Study contacts

Michaella Alexandrou, MD
Contact
michaella.alexandrou@allina.com
612-863-4768
Bavana Rangan, BDS, MPH
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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