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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07551999

Enrollment

Registered

2026-04-27

Start date

2026-05-01

Completion date

2028-07-01

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalomyelitis, Chronic Fatigue Syndrome

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).

Interventions

OTHERVoice 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of Mayo Speech Test (Voice Signatures) for Screening of ME/CFS	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.
Feasibility of Mayo Speech Test (Voice Signatures) for Monitoring of ME/CFS	12 weeks	Speech data will be analyzed alongside wearable data to assess feasibility of Mayo Speech Test for ME/CFS disease monitoring.

Secondary

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

Countries

United States

Contacts

CONTACTKatie Cruz

Cruz.Katie@mayo.edu507-284-5404

PRINCIPAL_INVESTIGATORStephanie L. Grach, MD, MS

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026