fMRI and Brainstem Evoked Response Audiometry (BERA) to Probe the Mechanism of Human Brain Auditory System in Tinnitus and Unilateral Hearing Loss

Completed

• Conditions: Ringing in the ear; 10019243

• Registration Number: NL-OMON52331
• Lead Sponsor: Keel-, Neus- en Oorheelkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

To be eligible to participate in this study, the subject
- must have in the age range of 18-80 years old.
- Audiogram: [35 dB =< (pure tone average in 2, 4, and 8 kHz) =< 65] for one
ear and audiogram [(pure tone average in 2, 4, and 8 kHz) < 30] for the other
ear, if the subject is in one of the unilateral hearing loss groups.
- Audiogram: [(pure tone average in 2, 4, and 8 kHz) < 30] for both ears, if
the subject is in one of the groups with no hearing loss.
- Audiogram: [(pure tone average in 0.25 0.5, and 1 kHz) < 30] for both ears,
for all the subjects

Exclusion Criteria

- Non-conformance to any of the inclusion criteria.
- Contraindication for MRI according to the MRI checklist.
- Reported medical, neurological, or psychiatric disorders (excluding tinnitus
and hearing loss).
- Using hearing aids

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints are differences between response characteristics associated<br /><br>with unilateral hearing loss and the presence of tinnitus. These differences<br /><br>are quantified as differences between the tonotopic map of the auditory cortex<br /><br>between the subject groups. Tonotopic maps are based on the MRI acquisitions. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A second study parameter is a difference in BERA peak amplitudes and latencies<br /><br>between the groups.</p><br>