Understanding the Consequences of Recreational Noise Exposure

December 15, 2023 updated by: University of Nottingham
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Noise exposure is the main cause of preventable hearing loss worldwide. Noise exposure occurs in the workplace, such as in noisy factories, and recreationally through the use of personal music players and attendance at nightclubs and live music events.

Hearing loss is usually diagnosed using pure tone audiometry, which measures the sensitivity of the ear to quiet sounds by determining the levels of tones that can just be heard at several test frequencies. Until recently, it had been assumed that hearing loss results mainly from damage to the sensory hair cells in the cochlea, the part of the ear that converts acoustic vibrations into electrical impulses in the cochlear nerve (CN). However, recent results from animal studies suggest that even moderate noise exposure can cause substantial damage to the CN, without any noticeable damage to the hair cells. Crucially, these results suggest that such damage does not immediately affect sensitivity to quiet sounds, but may exacerbate the effects of ageing.

Hearing loss is a huge problem. Substantial numbers of people, millions in the United Kingdom (UK) alone, are routinely exposed to significant levels of occupational and/or recreational noise. A large UK study found that one in seven adults aged 17-30 years reported "great difficulty" hearing speech in noisy backgrounds, while only one in fifty had impaired sensitivity as measured by pure tone audiometry. Hearing loss can lead to social isolation, depression, and is likely to be predictive of more severe hearing loss in old age. Recent studies suggest that hearing loss also reduces quality of life and is a risk factor for dementia.

This study is part of a programme grant conducted from April 2021 to March 2026 by The University of Manchester and The University of Nottingham. The overall aim of the programme is to understand the consequences of recreational noise exposure through improvement of the understanding of the contribution of CN damage to listening difficulties and audiometric losses.

The primary research questions are:

  1. How does auditory pathway integrity vary with noise exposure, audiometric / outer hair cell (OHC) loss, and age?
  2. How do auditory pathway integrity, audiometric loss, and OHC loss relate to listening difficulties? The secondary research question is to address how MRI measures relate to electrophysiological measures of auditory pathway integrity.

All participants will undergo the following non-invasive examinations:

  • Extended high frequency audiometry to 16 kHz.
  • Distortion Product Otoacoustic Emissions (DPOAEs): DPOAEs to 10.5 kHz.
  • Middle Ear Muscle Reflex (MEMR): using a broadband contralateral elicitor and a click probe.
  • Auditory Brainstem Response (ABR) to assess cochlear synaptopathy and central neural function. The ABR will be elicited with high-pass clicks.
  • Speech in noise: A masked speech test will comprise verbal stimuli presented through headphones. The signal-to-background ratio will be varied adaptively to determine reception threshold.
  • The Auditory Digit Span test to assess both forward and backward recall as a measurement of short term memory and working memory.
  • The Tinnitus Functional Index to assess the severity of tinnitus.
  • The Noise Exposure Structured Interview (NESI) to assess the lifetime noise exposure.
  • MR Neurography using structural Magnetic Resonance Imaging to visualise the cochlear nerve and measure the diameter/cross-sectional area.
  • High-resolution diffusion tensor imaging (DTI) to determine the apparent diffusion coefficient (ADC) and fractional anisotropy (FA) in the cochlear nerve.
  • Whole-brain DTI to measure the apparent diffusion coefficient (ADC) and fractional anisotropy (FA) in the ascending auditory pathway and auditory cortex.
  • High spatial resolution quantitative T1 mapping will be used to assess myelination in the ascending auditory pathway and auditory cortex.
  • High spatial resolution T1 weighted imaging will be used to assess morphometry in the ascending auditory pathway and auditory cortex.
  • Resting State Functional MRI, lasting 15 minutes, with eyes open and relaxed fixation, will be used to assess the functional connectivity in the ascending auditory pathway and auditory cortex.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG1 5DU
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
        • Recruiting
        • Sir Peter Mansfield Imaging Centre, University of Nottingham
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy individuals able to travel to the Sir Peter Mansfield Imaging Centre, University Park Campus of the University of Nottingham for up to three visits. Recruitment will be targeted to maximise the opportunities to recruit participants with noise exposure and suspected noise induced hearing loss.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1: young adults
50 adults aged 18-19 years, with low lifetime noise exposure and audiometric thresholds in the normal range for their age.
Group 2: older adults with low noise exposure
50 adults aged 30-50 years, with low lifetime noise exposure and audiometric thresholds in the normal range for their age.
Group 3: older adults with high noise exposure
50 adults aged 30-50 years, with high lifetime noise exposure and audiometric thresholds in the normal range for their age.
Group 4: older adults with suspected noise-induced hearing loss
50 adults aged 30-50 years, with high lifetime noise exposure and audiometric thresholds above the normal range for their age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory nerve health
Time Frame: Baseline
Auditory nerve diameter and/or surface area
Baseline
Auditory nerve health
Time Frame: Baseline
Diffusion measure in the auditory nerve (fractional anisotropy or apparent diffusion coefficient)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomical measure of the ascending auditory pathway
Time Frame: Baseline
Diffusion measure in the ascending auditory pathway (fractional anisotropy or apparent diffusion coefficient)
Baseline
Anatomical measure of the ascending auditory pathway
Time Frame: Baseline
Myelination measure in the ascending auditory pathway
Baseline
Anatomical measure of the ascending auditory pathway
Time Frame: Baseline
Morphometry measure in the ascending auditory pathway
Baseline
Functional measure of the ascending auditory pathway
Time Frame: Baseline
Resting state functional connectivity measure in the ascending auditory pathway
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Nottingham University Hospitals NHS Trust
University of Manchester
National Institute for Health Research Nottingham Biomedical Research Centre

Investigators

  • Principal Investigator: Susan T Francis, PhD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Estimated)

May 18, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21021
  • MR/V01272X/1 (Other Grant/Funding Number: Medical Research Council (MRC) Programme Grant)
  • 295085 (Other Identifier: IRAS Project ID)
  • 21/LO/0615 (Other Identifier: Research Ethics Committee)
  • 50341 (Other Identifier: Central Portfolio Management System (CPMS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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