ClinicalTrials.gg
RecruitingNCT07551999Updated May 27, 2026

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

An observational study in Encephalomyelitis and Chronic Fatigue Syndrome, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.

Primary conditionFatigue Syndrome, ChronicRegistry: EncephalomyelitisReclassifiedWhy we changed it
Registry
Encephalomyelitis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Fatigue Syndrome, Chronic
Why
  1. The study's listed conditions name Fatigue Syndrome, Chronic, a narrower term within Encephalomyelitis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Encephalomyelitis
  • Chronic Fatigue Syndrome

Browse trials for

03

In context

Fatigue Syndrome, Chronic Reclassified

263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.

This study's planned enrollment of 40 is below the median of 150 across 77 observational studies indexed under Fatigue Syndrome, Chronic.

Browse Fatigue Syndrome, Chronic studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Compared within Fatigue Syndrome, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Encephalomyelitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 heart failure or greater than moderate pulmonary hypertension.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

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

    Other: Voice Recording

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.

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What researchers measure

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07551999
Lead sponsor
Mayo Clinic
Responsible party
Stephanie L. Grach (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Apr 27, 2026
Start date
May 26, 2026
Primary completion
Dec 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
May 27, 2026

Study contacts

Katie Cruz
Contact
Cruz.Katie@mayo.edu
507-284-5404
Stephanie L. Grach, MD, MS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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