Hearing Loss Clinical Trial
Official title:
Understanding the Consequences of Recreational Noise Exposure
The aim of this study is to determine whether measures derived from Magnetic Resonance Imaging (MRI) scans, and clinical and behavioural measures of hearing loss, in the peripheral and central auditory system (ranging from the cochlear nerve through the auditory brainstem to the auditory cortex) are associated with age and history of noise exposure in otherwise healthy adult humans.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 31, 2026 |
Est. primary completion date | May 18, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Ability to give informed consent in English - In the age range stipulated for the group, i.e. 18-19 inclusive for group 1 and 30-50 inclusive for groups 2 - 4. - Audiometric thresholds in the range stipulated for the group, i.e. in the normal range for their age group for groups 1 - 3 and outside the normal range for their age group for group 4. - Noise exposure in the range stipulated for the group, as determined by the NESI, i.e. less than 15 units for groups 1 - 2 and 15 or more units for groups 3 - 4. Exclusion Criteria: - Contraindications for MRI - Motor impairment (for example, cerebral palsy) - Cognitive impairment (for example, dementia or brain injury) - Health conditions indicative of peripheral neuropathy (e.g. Type 1 diabetes). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hearing Theme, NIHR Nottingham Biomedical Research Centre, Ropewalk House, 113 The Ropewalk | Nottingham | Nottinghamshire |
United Kingdom | Sir Peter Mansfield Imaging Centre, University of Nottingham | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, University of Manchester |
United Kingdom,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Auditory nerve health | Auditory nerve diameter and/or surface area | Baseline | |
Primary | Auditory nerve health | Diffusion measure in the auditory nerve (fractional anisotropy or apparent diffusion coefficient) | Baseline | |
Secondary | Anatomical measure of the ascending auditory pathway | Diffusion measure in the ascending auditory pathway (fractional anisotropy or apparent diffusion coefficient) | Baseline | |
Secondary | Anatomical measure of the ascending auditory pathway | Myelination measure in the ascending auditory pathway | Baseline | |
Secondary | Anatomical measure of the ascending auditory pathway | Morphometry measure in the ascending auditory pathway | Baseline | |
Secondary | Functional measure of the ascending auditory pathway | Resting state functional connectivity measure in the ascending auditory pathway | Baseline |
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