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

NCT07551999 | Not Yet Recruiting

• 1 other identifier: 25-006484
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of Mayo Speech Test (Voice Signatures) for Screening of ME/CFS

  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

  Speech data will be analyzed alongside wearable data to assess feasibility of Mayo Speech Test for ME/CFS disease monitoring.

  12 weeks

Secondary Outcomes (1)

• Feasibility of Mayo Speech Test (Voice Signatures) for Severity of ME/CFS

  12 weeks

Study Arms (1)

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

Other: Voice Recording

Interventions

Voice Recording OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Encephalomyelitis; Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Central Nervous System Infections; Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephanie L. Grach, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Cruz

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)