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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr James Tysome
+44 1223 256051
jrt20@cam.ac.uk


Ms Karen James
-
starfish@trials.bham.ac.uk


Dr Matthew Smith
-
mes39@cam.ac.uk


Mr Samir Mehta
-
S.MEHTA.1@bham.ac.uk


Study Location:

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English | Cymraeg
Be Part of Research - Trial Details - A research study to find out whether steroids given by mouth, an injection through the ear drum, or a combination of both treatments is best at improving hearing after unexplained sudden hearing loss.

A research study to find out whether steroids given by mouth, an injection through the ear drum, or a combination of both treatments is best at improving hearing after unexplained sudden hearing loss.

Medical Conditions

Idiopathic sudden sensorineural hearing loss


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Hearing loss is a common and disabling condition that may result from problems with the cochlea, the inner ear structure that senses sound and sends information to the brain. Loss of hearing due to damage to the cochlea can occur suddenly and without an obvious cause, a condition described as sudden sensorineural hearing loss (SSNHL). SSNHL can range from a mild hearing loss to a completely deaf ear, which can make it difficult to understand people talking on the affected side. Recovery of hearing following SSNHL may be helped by urgent treatment with steroids, but crucially we do not know if these work best given as tablets or by an injection through the ear drum. If SSNHL is identified more than a few weeks after it occurs, steroids may have little effect. A major problem is that patients with SSNHL may not be referred to Ear, Nose and Throat (ENT) surgeons in time to benefit from steroid treatment (within four weeks), due to delays in the hearing loss being recognised or referred by general practitioners (GPs). Sudden hearing loss is rare and we usually do not know why it happens. Steroids are the best treatment to try and improve hearing, but we do not know whether it is best to give them by mouth or by an injection through the ear drum.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Feb 2023 30 Nov 2026

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38422002/ (added 01/03/2024)

People with sudden hearing loss of unknown cause will be randomly chosen to have steroid treatment by mouth, injection into their ear, or both together. They will have a hearing test and fill in questionnaires before treatment and then six weeks and three months later to see how well their hearing recovers, as well as measure their dizziness and ringing in their ears. One of the main problems with a trial like this is reaching patients with sudden hearing loss to encourage them to see their GP, and making sure their GPs refer them quickly to their local Ear Nose and Throat department for treatment. We will use a Facebook campaign to reach people with sudden hearing loss and encourage them to see their GP. We will use teaching sessions to remind GPs to refer straight away to their local hospital ENT department. As these patients are usually seen by junior ENT doctors, we will use a national group of junior ENT doctors to let patients know about the trial.


Adults aged 18 years or over with ISSNHL in the last 4 weeks.

You can take part if:



You may not be able to take part if:


1. Identified cause for hearing loss (not idiopathic)2. Bilateral ISSNHL3. Received prior steroid treatment for the same episode of ISSNHL4. Medical contraindication to high dose systemic steroids5. Previous history of psychosis6. On oral steroid therapy for another condition7. Known adrenocortical insufficiency other than exogenous corticosteroid therapy8. Hypersensitivity to the active substance or to any of the excipients9. Has a systemic infection unless specific anti-infective therapy is employed10. Has ocular herpes simplex11. Has ipsilateral acute or chronic active middle ear disease (including acute otitis media, chronic suppurative otitis media and cholesteatoma, excluding dry perforation)12. Does not have the capacity to provide written informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Freeman Road Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Queen Alexandras Hospital
    Southwick Hill Road Cosham
    Portsmouth
    PO6 3LY
  • Royal Blackburn Hospital
    Haslingden Road
    Blackburn
    BB2 3HH
  • University College London Hospitals NHS Foundation Trust
    250 Euston Road
    London
    NW1 2PG
  • Ninewells Hospital
    Ninewells Avenue
    Dundee
    DD1 9SY
  • Aberdeen Royal Infirmary
    Foresterhill Road
    Aberdeen
    AB25 2ZN
  • University Hospital of Wales
    Heath Park
    Cardiff
    CF14 4XW
  • Royal United Hospitals Bath NHS Foundation Trust
    Combe Park
    Bath
    BA1 3NG
  • Royal Hallamshire Hospital
    Glossop Road
    Sheffield
    S10 2JF
  • Royal Stoke University Hospital
    Newcastle Road
    Stoke-on-trent
    ST4 6QG
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • Royal Free London NHS Foundation Trust
    Royal Free Hospital Pond Street
    London
    NW3 2QG
  • Taunton Hospital
    Musgrove Park Hospital
    Taunton
    TA1 5DA
  • Queen Elizabeth University Hospital
    1345 Govan Road
    Glasgow
    G51 4TF
  • Addenbrookes
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • Royal Berkshire Hospital
    Royal Berkshire Hospital London Road
    Reading
    RG1 5AN
  • Royal Derby Hospital
    Uttoxeter Road
    Derby
    DE22 3NE
  • Glasgow Royal Infirmary
    84 Castle Street
    Glasgow
    G4 0SF
  • University Hospital Coventry & Warwickshire
    Clifford Bridge Road Walsgrave
    Coventry
    CV2 2DX
  • Leeds General Infirmary
    Great George Street
    Leeds
    LS1 3EX
  • The James Cook University Hospital
    Marton Road
    Middlesbrough
    TS4 3BW
  • Lister Hospital
    Coreys Mill Lane
    Stevenage
    SG1 4AB
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • University Hospital Birmingham
    Queen Elizabeth Hospital Edgbaston
    Birmingham
    B15 2TH
  • Queens Hospital
    Belvedere Road
    Burton-on-trent
    DE13 0RB
  • Manchester Royal Royal Infirmary
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • Great Western Hospitals NHS Foundation Trust
    Great Western Hospital Marlborough Road
    Swindon
    SN3 6BB
  • Liverpool University Hospitals NHS Foundation Trust
    Royal Liverpool University Hospital Prescot Street
    Liverpool
    L7 8XP
  • Salford Royal Hospital
    Stott Lane Eccles
    Salford
    M6 8HD
  • Charing Cross Hospital
    Fulham Palace Road
    London
    W6 8RF
  • Queens Medical Centre
    Nottingham University Hospital Derby Road
    Nottingham
    NG7 2UH
  • Royal Devon and Exeter Hospital
    Royal Devon & Exeter Hospital Barrack Road
    Exeter
    EX2 5DW
  • Royal Victoria Hospital
    274 Grosvenor Road
    Belfast
    BT12 6BA
  • Wythenshawe Hospital
    Southmoor Road Wythenshawe
    Manchester
    M23 9LT
  • Hinchingbrooke Hospital
    Hinchingbrooke Park
    Huntingdon
    PE29 6NT
  • Morriston Hospital
    Heol Maes Eglwys Cwmrhydyceirw
    Swansea
    SA6 6NL
  • Kingston Hospital
    Galsworthy Road
    Kingston upon Thames
    KT2 7QB
  • James Paget University Hospital
    Lowestoft Road Gorleston
    Great Yarmouth
    NR31 6LA
  • Gloucestershire Royal Hospital
    Great Western Road
    Gloucester
    GL1 3NN
  • Broomfield Hospital
    Court Road Broomfield
    Chelmsford
    CM1 7ET
  • Bolton Royal Hospital
    Minerva Road Farnworth
    Bolton
    BL4 0JR
  • Torbay Hospital
    Newton Road
    Torquay
    TQ2 7AA
  • Countess of Chester Hospital
    Countess of Chester Health Park Liverpool Road
    Chester
    CH2 1UL
  • Royal Lancaster Infirmary
    Ashton Road
    Lancaster
    LA1 4RP
  • Peterborough City Hospital
    Edith Cavell Campus Bretton Gate Bretton
    Peterborough
    PE3 9GZ
  • Wrexham Maelor Hospital
    Croesnewydd Road Wrexham Technology Park
    Wrexham
    LL13 7TD
  • Colchester General Hospital
    Colchester District General Hosp. Charter Way Turner Road
    Colchester
    CO4 5JL
  • Tameside General Hospital
    Fountain Street
    Ashton-under-lyne
    OL6 9RW
  • Sandwell General Hospital
    Lyndon
    West Bromwich
    B71 4HJ
  • Thomas Linacre Centre
    Parsons Walk
    Wigan
    WN1 1RU
  • Wexham Park Hospital
    Wexham Street Wexham
    Slough
    SL2 4HL
  • North West London Hospitals NHS Trust
    Northwick Park Hospital Watford Road
    Harrow
    HA1 3UJ
  • Monklands Hospital
    Monkscourt Avenue
    Airdrie
    ML6 0JS
  • Stepping Hill Hospital
    Poplar Grove Hazel Grove
    Stockport
    SK2 7JE
  • Poole
    Poole Hospital Longfleet Road
    Poole
    BH15 2JB
  • Furness Hospitals NHS Trust
    Furness General Hospital Dalton Lane
    Barrow-in-furness
    LA14 4LF
  • West Wales General Hospital
    Glangwili
    Carmarthen
    SA31 2AF
  • Kettering General Hospital Laboratory
    Kettering General Hospital Rothwell Road
    Kettering
    NN16 8UZ
  • Lincoln County Hospital
    Sewell Road
    Lincoln
    LN2 5QY
  • Princess Royal Hospital
    Apley Castle, Grainger Drive Apley
    Telford
    TF1 6TF
  • Inhealth - Southend Pet/ct
    Southend University Hospital Prittlewell Chase
    Westcliff-on-sea
    SS0 0RY
  • St Johns Hospital
    Howden Road West
    Livingston
    EH54 6PP
  • Ysbyty Gwynedd Day Hospital
    Ysbyty Gwynedd Penrhosgarnedd
    Bangor
    LL57 2PW

Benefits:
This group have already been very successful if previous work at recruiting patients to research studies. We have worked with a group of patients who had sudden hearing loss to make sure that this research study is designed well and measures the issues that they felt were important. They thought that it would be a good idea to be able to test their hearing at home during the study as well as coming into the hospital for their hearing tests. We therefore included some hearing tests that can be performed on a smartphone, tablet or desktop computer at home for those patients who have one of these devices. The results of the research study will be shared with the public through our Facebook group, a website and newsletters as well as GPs, emergency doctors and ENT doctors through talks at meetings and changing guidelines for the treatment of sudden hearing loss.
Risks:
Interventions:
- Both oral and injected steroid are commonly used treatments for ISSNHL in the UK with a good safety profile.
- Short-course high dose oral steroids have few risks if given according to the protocol. The most common side effects are altered mood or poor sleep, and these resolve when treatment finishes.
- Exclusion criteria ensure that patients at greater risk of side effects (e.g. pregnant women) are excluded.
- Intratympanic injection also has an established safety profile. It may be briefly uncomfortable, cause vertigo and occasionally infection and patients will be warned of these risks during the consent process and in specific patient information sheets for each treatment arm.
- Very rarely transtympanic injection could cause further permanent hearing loss, usually technique-related. Investigators performing injection will be required to review training material (written and video) and trainees/surgeons new to the technique will be supervised.
- Written instructions will be provided to participants regarding their allocated treatment, including information on side effects and who to contact in the event of a problem.
- GPs will be informed of the allocated treatment.
Research procedures:
- Additional research procedures include in-hospital speech hearing tests, questionnaires, and for some patients home hearing assessment.
- The main burden on participants is that slightly longer appointments will be required than those of standard of care. Follow up has been reduced to the minimum possible, and designed to coincide with standard care appointments.
- Although the questionnaires do not address sensitive issues, participants may find completing the questionnaires slightly distressing, or a burden on time. This risk will be explained during consent.
- Participants will be encouraged to perform online hearing tests weekly. Given potential time burdens or difficulty with internet access, these are optional. The tests are provided by an established developer of online hearing assessment tools and are designed to be simple to use with personal electronic devices and headphones.
Comprehension:
- Trial information will be made available in video and written format to maximise accessibility. The information sheet has been reviewed by patients to ensure accessibility.
Confidentiality:
- The trial is designed in accordance with the Birmingham Clinical Trials Unit (BCTU) Standard Operating Procedures.
- Site researchers will follow local NHS Trust policy on Data Protection.
- In correspondence, identifiers will be limited to Trial ID ± partial date of birth.
- Home hearing testing data will be associated with a code separate to the trial ID to ensure effective pseudo-anonymisation.

Mr Samir Mehta
-
S.MEHTA.1@bham.ac.uk


Dr Matthew Smith
-
mes39@cam.ac.uk


Dr James Tysome
+44 1223 256051
jrt20@cam.ac.uk


Ms Karen James
-
starfish@trials.bham.ac.uk



The study is sponsored by University of Birmingham and funded by National Institute for Health and Care Research.




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Read full details for Trial ID: ISRCTN10535105

Or CPMS 53517

Last updated 08 October 2024

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