A Study Of Remote Voice Analysis Tool For Diagnosing And Monitoring ME/CFS

May 26, 2026 updated by: Stephanie L. Grach, Mayo Clinic

Use Of A Remote Voice Analysis Tool For Diagnosing And Monitoring Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Stephanie L. Grach, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from the Mayo Clinic Division of General Internal Medicine which includes the Fibromyalgia & Chronic Fatigue Syndrome Clinic, Post-COVID Care Clinic, and Consultative Medicine Clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Mayo Speech Test (Voice Signatures) for Screening of ME/CFS
Time Frame: 12 weeks

Speech data will be analyzed for voice signatures that can be differentiated from people with ME/CFS and those without ME/CFS.

data will be analyzed for voice signatures that can be differentiated from people with ME/CFS and those without ME/CFS.
12 weeks
Feasibility of Mayo Speech Test (Voice Signatures) for Monitoring of ME/CFS
Time Frame: 12 weeks
Speech data will be analyzed alongside wearable data to assess feasibility of Mayo Speech Test for ME/CFS disease monitoring.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Mayo Speech Test (Voice Signatures) for Severity of ME/CFS
Time Frame: 12 weeks
Speech data will be analyzed for voice signatures that can differentiate by severity level within ME/CFS (mild, moderate, severe, very severe).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Stephanie L. Grach, MD, MS, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-006484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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