Recruiting

Observational Study

Sponsor:

Minneapolis Heart Institute Foundation

Code:

NCT07780812

Conditions

Burnout

Burnout, Healthcare Workers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Calmigo

Study Details

Brief summary:

This project aims to explore how speech patterns and voice characteristics can be used to detect signs of burnout and stress in physicians.

Conditions

Burnout

Burnout, Healthcare Workers

Study ID

NCT07780812

Start date

Jun 2, 2025

Status verified date

Aug, 2026

Completion date

Oct 2, 2027

Anticipated

Primary completion date

Jun 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 malignancy
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.)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention Arm

Calmigo device

no intervention: No intervention

no intervention

Interventions

Calmigo

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

Primary outcome measure

  • Mini-Z 2.0 survey score [ Time Frame: 12 weeks ]
  • Maslach Burnout Inventory (MBI) survey score [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Minneapolis Heart Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

More Information

Sponsor

Minneapolis Heart Institute Foundation

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • voice biomarkers
  • voice-b
  • burnout

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Heart Institute Foundation on 2026-08-24.