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

N/ARecruitingNCT07551999

Mayo Clinic40 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Encephalomyelitis Chronic Fatigue Syndrome

Interventions

Voice RecordingOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Katie Cruz

CONTACT

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

Data from ClinicalTrials.gov

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