A Study to Evaluate Hearing in Young Adults After Exposure to 3.0T MRI with Routine Hearing Protections
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: 17-002548
Sponsor Protocol Number: 17-002548
About this study
The purpose of this study is to establish whether exposure to 3.0T MRI acoustic noise can induce temporary or permanent hearing threshold shifts or otoacoustic emissions amplitude shifts in patients using the currently accepted routine hearing protection.
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:
- Patients scheduled to have a 3T MRI in the Neuroradiology practice.
- Male and female patients in the age range of 18-55 years old.
- Hearing ability verified by hearing thresholds no worse than 25 dB HL 0.25 to 4 kHz.
Exclusion Criteria:
- Patients with a history of prior ear surgery, ear drainage in the last 90 days, otalgia, ear fullness, fluctuating hearing loss, or conductive and/or mixed hearing loss.Hearing thresholds exceeding 25 dB HL 0.25 to 4 kHz which is considered mild hearing loss or greater4.
- Claustrophobia, cardiac pacemaker/wires in place, or any absolute contraindication to MRI
- Inability to provide own consent
- Uncompleted MRI scan
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 Carrie Carr, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available