NCT05076344

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

May 19, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

July 9, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

September 28, 2021

Last Update Submit

July 4, 2025

Conditions

Hearing LossHearing Loss, Noise-Induced

Keywords

central nervous systemperipheral nervous systemmagnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

  • Auditory nerve health

    Auditory nerve diameter and/or surface area

    Baseline

  • Auditory nerve health

    Diffusion measure in the auditory nerve (fractional anisotropy or apparent diffusion coefficient)

    Baseline

Secondary Outcomes (4)

  • Anatomical measure of the ascending auditory pathway

    Baseline

  • Anatomical measure of the ascending auditory pathway

    Baseline

  • Anatomical measure of the ascending auditory pathway

    Baseline

  • Functional measure of the ascending auditory pathway

    Baseline

Study Arms (4)

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.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hearing Theme, NIHR Nottingham Biomedical Research Centre, Ropewalk House, 113 The Ropewalk

Nottingham, Nottinghamshire, NG1 5DU, United Kingdom

Location

Sir Peter Mansfield Imaging Centre, University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Location

Related Publications (14)

  • 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.

    PMID: 10713509BACKGROUND

  • 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.

    PMID: 16481444BACKGROUND

  • 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.

    PMID: 19246693BACKGROUND

  • 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.

    PMID: 29067347BACKGROUND

  • 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.

    PMID: 32738937BACKGROUND

  • 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.

    PMID: 30295145BACKGROUND

  • 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.

    PMID: 22156949BACKGROUND

  • 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.

    PMID: 24599597BACKGROUND

  • 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.

    PMID: 23319716BACKGROUND

  • 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.

    PMID: 28566097BACKGROUND

  • 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.

    PMID: 25147195BACKGROUND

  • 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.

    PMID: 27003148BACKGROUND

  • 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.

    PMID: 25638217BACKGROUND

  • 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.

    PMID: 22484410BACKGROUND

MeSH Terms

Conditions

Hearing LossHearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss, Sensorineural

Study Officials

  • Susan T Francis, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 13, 2021

Study Start

May 19, 2022

Primary Completion

March 25, 2025

Study Completion

March 25, 2025

Last Updated

July 9, 2025

Record last verified: 2025-03

Locations

GB(2)