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NCT Number: NCT07551999

A Study Of Remote Voice Analysis Tool For Diagnosing And Monitoring 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Katie Cruz

CONTACT

[email protected]

507-284-5404

Stephanie L. Grach, MD, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Cruz

CONTACT

[email protected]

507-284-5404

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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