Health TrialsbyHealthPanel

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

ConditionsEncephalomyelitisChronic Fatigue Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Voice Recording

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patients diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks

Secondary outcomes

1

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

Speech data will be analyzed for voice signatures that can differentiate by severity level within ME/CFS (mild, moderate, severe, very severe).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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