Recruiting

Voice-Based Tool

Sponsor:

Mayo Clinic

Code:

NCT07551999

Conditions

Encephalomyelitis

Chronic Fatigue Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Voice Recording

Study Details

Brief summary:

The purpose of this research is to evaluate the use of a voice-based tool in the diagnosis and management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Conditions

Encephalomyelitis

Chronic Fatigue Syndrome

Study ID

NCT07551999

Start date

May 26, 2026

Status verified date

May, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) verified by an ME/CFS specialist.
  • Ability to complete study questionnaires and provide voice samples using a smartphone application.
  • Consistent access to a smartphone or tablet with iOS or Android operating systems, or a laptop.

Exclusion Criteria:

  • No diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS); "Chronic Fatigue Syndrome" not verified by an ME/CFS specialist.
  • Lack of consistent access to a smartphone or tablet with iOS or Android operating systems, or laptop.
  • Known dementia or other neurodegenerative disorder prominently affecting cognition or speech patterns. outside of ME/CFS
  • Known history of voice disorder either primary or secondary to neuromuscular or other pathology outside of ME/CFS
  • Known clinically significant heart failure or greater than moderate pulmonary hypertension.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

Interventions

Voice Recording

Patients will create 5 - 10 minute voice recordings that include counting, vowel prolongation, alternating speed, and word repetition, every 2 weeks, for a total of 12 weeks. Recordings will be collected using the Visible mobile application, and patients will wear the Visible Armband 2.0 while recording.

Primary outcome measure

  • Feasibility of Mayo Speech Test (Voice Signatures) for Screening of ME/CFS [ Time Frame: 12 weeks ]
  • Feasibility of Mayo Speech Test (Voice Signatures) for Monitoring of ME/CFS [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Katie Cruz

507-284-5404Cruz.Katie@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Katie Cruz

507-284-5404Cruz.Katie@mayo.edu

Principal Investigator:

Stephanie L. Grach, MD, MS

More Information

Sponsor

Mayo Clinic

Last update posted

May 27, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.