This site is optimised for modern browsers. For the best experience, please use Google Chrome, Mozilla Firefox, or Microsoft Edge.

Beta

This is a new site which is still under development. We welcome your feedback, which will help improve it.

Feedback form

19/128 Administration routes of steroids in the first-line treatment of idiopathic sudden sensorineural hearing loss

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research Question:

What is the most effective route of administration of steroids as a first-line treatment for idiopathic sudden sensorineural hearing loss?

  1. Interventions: Oral steroids, intra-tympanic steroids or combined oral/intratympanic steroids as first line treatment. Applicants should specify and justify their choice of administration routes to be investigated, as well as their choice of steroid/s, and dosage.
  2. Patient group: Adults of any age presenting with new-onset idiopathic sudden sensorineural hearing loss. 
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: ENT settings and any other suitable setting. 
  4. Comparator: The study should include a comparison between different routes of steroid administration. Double dummy techniques may be considered to mask the intervention. 
  5. Study design: Applicants should consider the most appropriate randomised design to address the uncertainty between the treatment options. The study should include an internal pilot phase to test the acceptability of the proposed interventions, and the ability to recruit, randomise, and retain.
    Applicants are encouraged to refer to the international consensus statement on treatment of sudden sensorineural hearing loss and methodological guidance for future research (https://doi.org/10.1016/j.anorl.2017.12.011). 
  6. Important outcomes: Functional improvement and recovery. (Applicants should explain and justify how these will be assessed.)
    Other outcomes: Changes in pure tone audiometry; adverse events; time to recovery; quality of life; acceptability; cost-effectiveness. Applicants may wish to consider the time between the onset of hearing loss and start of treatment and whether this would affect outcomes. 
  7. Minimum duration of follow-up: 2 months. 
    Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale:

Sudden sensorineural hearing loss (SSNHL, also known as 'sudden deafness') is a rapid loss of hearing that can occur over a few hours or up to three days. It typically occurs in one ear only. The hearing loss in the affected ear can range from mild to total and can be temporary or permanent. In the vast majority of patients, the cause of SSNHL cannot be identified, and this condition is known as 'idiopathic sudden sensorineural hearing loss' (idiopathic SSNHL). SSNHL is considered an ENT emergency that requires immediate or urgent referral to specialist medical care, as stipulated in the NICE quality standard on hearing loss [QS185].

The mainstay of treatment currently consists of early initiation of steroids. These can include oral steroids (by mouth), intra-tympanic steroid injections (injection of steroids through the eardrum into the middle ear, also known as trans-tympanic injections), or a combination of both. Although UK and international guidelines recommend steroid treatments, there is currently a paucity of evidence assessing these treatments. Therefore, it is difficult to establish the most clinically and cost effective route of administration of steroids as first-line treatment for idiopathic SSNHL.

NICE, in their recent guideline on hearing loss [NG98], has therefore issued a high-priority research recommendation to answer this question. The suggested research is expected to inform future updates of key recommendations in this guideline.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 1st April 2020. Applications will be considered by the HTA Funding Committee at its meeting in May 2020.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in September 2020.

Applications received electronically after 1300 hours on the due date will not be considered.

Should you have any queries please contact us:

Email:   
htacommissioning@nihr.ac.uk 

Telephone:  
Commissioning Funding Committee 02380 595510