EncephalomyelitisNCT07551999
A Study Of Remote Voice Analysis Tool For Diagnosing And Monitoring ME/CFS
An observational study of Encephalomyelitis and Chronic Fatigue Syndrome, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Encephalomyelitis, Chronic Fatigue Syndrome
- What is being tested?
- Voice Recording
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Katie Cruz, 507-284-5404, Cruz.Katie@mayo.edu
Stephanie L. Grach, MD, MS
About this study
Official title: Use Of A Remote Voice Analysis Tool For Diagnosing And Monitoring Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (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).
- Conditions
- Encephalomyelitis, Chronic Fatigue Syndrome
- Being tested
- Voice Recording
- Medical subject headings
- Encephalomyelitis, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) | Not described Receives: Other: Voice Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start26 May 2026
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EncephalomyelitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie L. Grach, Mayo Clinic
- Investigators
- Stephanie L. Grach, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551999
- Sponsor's protocol ID
- 25-006484
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of A Remote Voice Analysis Tool For Diagnosing And Monitoring Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS)
- ClinicalTrials.gov ID
- NCT07551999
- Acronym / sponsor ID
- 25-006484
- Conditions
- Encephalomyelitis, Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) | – | Other: Voice Recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice RecordingPatients 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. | Other | Patients diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) |
Primary outcome
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.
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.
1 secondary outcome
Feasibility of Mayo Speech Test (Voice Signatures) for Severity of ME/CFS
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie L. Grach, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalomyelitis and Chronic Fatigue Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Cruz (507-284-5404, Cruz.Katie@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Mayo Speech Test (Voice Signatures) for Screening of ME/CFS (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.