Hearing LossNCT05076344
Understanding the Consequences of Recreational Noise Exposure
An observational study of Hearing Loss and Hearing Loss, Noise-Induced, run by University of Nottingham at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Hearing Loss, Noise-Induced
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 May 2022to 25 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hearing Theme, NIHR Nottingham Biomedical Research Centre, Ropewalk House, 113 The Ropewalk
Nottingham, Nottinghamshire, NG1 5DU
Sir Peter Mansfield Imaging Centre, University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
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.
Read the 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:
- How does auditory pathway integrity vary with noise exposure, audiometric / outer hair cell (OHC) loss, and age?
- 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.
- Conditions
- Hearing Loss, Hearing Loss, Noise-Induced
- Keywords
- central nervous system, peripheral nervous system, magnetic resonance imaging
- Medical subject headings
- Hearing Loss, Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Auditory nerve health
Auditory nerve diameter and/or surface area
Measured: Baseline
Auditory nerve health
Diffusion measure in the auditory nerve (fractional anisotropy or apparent diffusion coefficient)
Measured: Baseline
Secondary outcomes (4)
Anatomical measure of the ascending auditory pathway
Diffusion measure in the ascending auditory pathway (fractional anisotropy or apparent diffusion coefficient)
Measured: Baseline
Anatomical measure of the ascending auditory pathway
Myelination measure in the ascending auditory pathway
Measured: Baseline
Anatomical measure of the ascending auditory pathway
Morphometry measure in the ascending auditory pathway
Measured: Baseline
Functional measure of the ascending auditory pathway
Resting state functional connectivity measure in the ascending auditory pathway
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start19 May 2022
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Nottingham University Hospitals NHS Trust, Nottingham Biomedical Research Centre
- Responsible party
- Sponsor
- Investigators
- Susan T Francis, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076344
- Sponsor's protocol ID
- 21021
- Other IDs
- MR/V01272X/1, 295085, 21/LO/0615, 50341
- Status last verified
- Mar 2025
- First submitted
- 28 Sep 2021
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10713509Kujawa 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.
PubMed 16481444Gopinath 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.
PubMed 19246693Deal 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.
PubMed 29067347Livingston 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.
PubMed 32738937Guest 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.
PubMed 30295145Meikle 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.
PubMed 22156949Li 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.
PubMed 24599597Yan 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.
PubMed 23319716Tahir 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.
PubMed 28566097van 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.
PubMed 25147195Peng 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.
PubMed 27003148Kasper 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.
PubMed 25638217Zhang 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.
PubMed 22484410
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Consequences of Recreational Noise Exposure
- ClinicalTrials.gov ID
- NCT05076344
- Acronym / sponsor ID
- 21021
- Conditions
- Hearing Loss, Hearing Loss, Noise-Induced
- Keywords
- central nervous system, peripheral nervous system, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University of Manchester, Nottingham University Hospitals NHS Trust, Nottingham Biomedical Research Centre
- Study start
- 19 May 2022 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- How does auditory pathway integrity vary with noise exposure, audiometric / outer hair cell (OHC) loss, and age?
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Auditory nerve health
Time frame: Baseline
Auditory nerve diameter and/or surface area
Auditory nerve health
Time frame: Baseline
Diffusion measure in the auditory nerve (fractional anisotropy or apparent diffusion coefficient)
4 secondary outcomes
Anatomical measure of the ascending auditory pathway
Time frame: Baseline
Anatomical measure of the ascending auditory pathway
Time frame: Baseline
Anatomical measure of the ascending auditory pathway
Time frame: Baseline
Functional measure of the ascending auditory pathway
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 10713509Gates 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.
- Background: PubMed 16481444Kujawa 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.
- Background: PubMed 19246693Gopinath 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.
- Background: PubMed 29067347Deal 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.
- Background: PubMed 32738937Livingston 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.
- Background: PubMed 30295145Guest 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.
- Background: PubMed 22156949Meikle 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.
- Background: PubMed 24599597Li 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.
- Background: PubMed 23319716Yan 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.
- Background: PubMed 28566097Tahir 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.
- Background: PubMed 25147195van 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.
- Background: PubMed 27003148Peng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan T Francis, PhD principal investigator
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Hearing Loss, Noise-Induced, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory nerve health (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076344, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.