A Study Of Remote Voice Analysis Tool For Diagnosing And Monitoring ME/CFS
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 25-006484
About this study
The purpose of this study is to assess the utility of a voice and speech-based remote application in screening/diagnosis, severity grading, and monitoring of ME/CFS.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) verified by an ME/CFS specialist.
Aged 18 years or older.
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.
Aged 17 years or younger.
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.
Non-English speakers are excluded as the voice analysis technology to record the speech patterns is only configured for English at this time. Prisoners will be excluded as they may not be able to make a truly uncoerced decision regarding participation in research studies. Pregnant individuals will be excluded at the enrollment stage of Aim 1 and Aim 2 of this study, as voice changes can occur during pregnancy as related to body composition and hormone levels, which would be a confounding factor. If a participant becomes pregnant while participating in Aim 1 or Aim 2, they may continue as there is no harm to the participant or unborn fetus from the study. However, they must notify study personnel so potential confounders can be factored in. Pregnant and nursing individuals will be excluded from the Exploratory Aim as rapamycin crosses the placental barrier and may present harm to an unborn fetus, and effects through breastmilk are currently unknown. If a participant becomes pregnant during the Exploratory Aim, they must stop participating in the study as long as they are pregnant and/or nursing. All potential subjects, regardless, will be approached or invited to participate if study criteria are met.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/10/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Stephanie Grach, M.D., M.S. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available