Understanding the Consequences of Recreational Noise Exposure

Hearing Loss Clinical Trial

Official title:

Understanding the Consequences of Recreational Noise Exposure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05076344
• Other study ID #: 21021
• Secondary ID: MR/V01272X/12950
• Status: Recruiting
• Start date: May 19, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: December 2023
• Source: University of Nottingham
• Contact: Rebecca S Dewey, PhD
• Phone: 07762187556
• Email: rebecca.dewey[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University of Nottingham	National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (14)

Deal JA, Albert MS, Arnold M, Bangdiwala SI, Chisolm T, Davis S, Eddins A, Glynn NW, Goman AM, Minotti M, Mosley T, Rebok GW, Reed N, Rodgers E, Sanchez V, Sharrett AR, Coresh J, Lin FR. A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: Results from the Aging and Cognitive Health Evaluation in Elders Pilot Study. Alzheimers Dement (N Y). 2017 Jun 21;3(3):410-415. doi: 10.1016/j.trci.2017.06.003. eCollection 2017 Sep. — View Citation

Gates GA, Schmid P, Kujawa SG, Nam B, D'Agostino R. Longitudinal threshold changes in older men with audiometric notches. Hear Res. 2000 Mar;141(1-2):220-8. doi: 10.1016/s0378-5955(99)00223-3. — View Citation

Gopinath B, Schneider J, Rochtchina E, Leeder SR, Mitchell P. Association between age-related hearing loss and stroke in an older population. Stroke. 2009 Apr;40(4):1496-8. doi: 10.1161/STROKEAHA.108.535682. Epub 2009 Feb 26. — View Citation

Guest H, Dewey RS, Plack CJ, Couth S, Prendergast G, Bakay W, Hall DA. The Noise Exposure Structured Interview (NESI): An Instrument for the Comprehensive Estimation of Lifetime Noise Exposure. Trends Hear. 2018 Jan-Dec;22:2331216518803213. doi: 10.1177/2331216518803213. — View Citation

Kasper JM, Wadhwa V, Scott KM, Rozen S, Xi Y, Chhabra A. SHINKEI--a novel 3D isotropic MR neurography technique: technical advantages over 3DIRTSE-based imaging. Eur Radiol. 2015 Jun;25(6):1672-7. doi: 10.1007/s00330-014-3552-8. Epub 2015 Feb 1. — View Citation

Kujawa SG, Liberman MC. Acceleration of age-related hearing loss by early noise exposure: evidence of a misspent youth. J Neurosci. 2006 Feb 15;26(7):2115-23. doi: 10.1523/JNEUROSCI.4985-05.2006. — View Citation

Li Y, Yang J, Liu J, Wu H. Restudy of malformations of the internal auditory meatus, cochlear nerve canal and cochlear nerve. Eur Arch Otorhinolaryngol. 2015 Jul;272(7):1587-96. doi: 10.1007/s00405-014-2951-4. Epub 2014 Mar 6. — View Citation

Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available. Erratum In: Lancet. 2023 Sep 30;402(10408):1132. — View Citation

Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0. Erratum In: Ear Hear. 2012 May;33(3):443. — View Citation

Peng L, Xiao Y, Liu L, Mao Z, Chen Q, Zhou L, Liao B, Liu A, Wang X. Evaluation of cochlear nerve diameter and cross-sectional area in ANSD patients by 3.0-Tesla MRI. Acta Otolaryngol. 2016 Aug;136(8):792-9. doi: 10.3109/00016489.2016.1159329. Epub 2016 Mar 22. — View Citation

Tahir E, Bajin MD, Atay G, Mocan BO, Sennaroglu L. Bony cochlear nerve canal and internal auditory canal measures predict cochlear nerve status. J Laryngol Otol. 2017 Aug;131(8):676-683. doi: 10.1017/S0022215117001141. Epub 2017 Jun 1. — View Citation

van der Jagt MA, Brink WM, Versluis MJ, Steens SC, Briaire JJ, Webb AG, Frijns JH, Verbist BM. Visualization of human inner ear anatomy with high-resolution MR imaging at 7T: initial clinical assessment. AJNR Am J Neuroradiol. 2015 Feb;36(2):378-83. doi: 10.3174/ajnr.A4084. Epub 2014 Aug 21. — View Citation

Yan F, Li J, Xian J, Wang Z, Mo L. The cochlear nerve canal and internal auditory canal in children with normal cochlea but cochlear nerve deficiency. Acta Radiol. 2013 Apr 1;54(3):292-8. doi: 10.1258/ar.2012.110596. Epub 2013 Jan 14. — View Citation

Zhang H, Schneider T, Wheeler-Kingshott CA, Alexander DC. NODDI: practical in vivo neurite orientation dispersion and density imaging of the human brain. Neuroimage. 2012 Jul 16;61(4):1000-16. doi: 10.1016/j.neuroimage.2012.03.072. Epub 2012 Mar 30. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

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