A Study to Evaluate the Hearing Phenotype of Individuals with Mitochondrial Disease
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: 21-004870
About this study
The purpose of this study is to describe the hearing phenotype of individuals with mitochondrial disease and to determine if early investigation of hearing loss would result in earlier diagnosis of mitochondrial disease.
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:
- Individuals ages 18-65, inclusive.
- Known history of sensorineural or mixed hearing loss (not known to be due to infection) or history of hearing loss of unknown etiology.
- Positive MITOP test result (only for the retrospective analysis-Part 1).
Exclusion Criteria:
- Patients < 18 years or > 65 years.
- Patients or guardians of patients unable to provide informed consent.
- Patients using implantable hearing devices (ex. Cochlear implant, osseointegrated devices, etc.).
- Patients with sudden changes (or fluctuating) hearing (bilateral or unilateral).
- Patients with ear drainage and/or ear pain noted (bilateral or unilateral).
- Patients unable to provide informed consent or whose legal guardian cannot provide informed consent.
- Patients unable to perform GoAudio hearing test due to intellectual disability.
- Patients with no motor control of fingers.
- Patient with known/confirmed active conductive hearing loss.
- Negative MITOP test result (only for the retrospective analysis-Part 1).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available