NCT07780812

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
13mo left

Started Jun 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jun 2025Oct 2027

Study Start

First participant enrolled

June 2, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2027

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 17, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

voice biomarkersvoice-bburnout

Outcome Measures

Primary Outcomes (2)

  • Mini-Z 2.0 survey score

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

    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

    12 weeks

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

Calmigo device

Device: Calmigo

No intervention

NO INTERVENTION

no intervention

Interventions

CalmigoDEVICE

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

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Michaella Alexandrou, MD

CONTACT

Bavana Rangan, BDS, MPH

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 24, 2026

Study Start

June 2, 2025

Primary Completion (Estimated)

June 2, 2027

Study Completion (Estimated)

October 2, 2027

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Locations