Sudden Hearing Loss RCT


We are delighted to partner with INTEGRATE to deliver a large multicentre trial exploring the effectiveness of steroids given via different routes for idiopathic sudden sensorineural hearing loss (ISSNHL). This trial has provisionally been awarded funding by the NIHR Health Technology Assessment funding stream. 

The trial

The primary objective of the 3-arm trial is to establish whether first-line oral, intratympanic, or a combination of oral and intratympanic steroids are most effective at achieving functional hearing recovery in adults with ISSNHL. The innovative methodology of the trial also aims to improve the early identification of ISSNHL in primary care, and to measure the trajectory of hearing recovery.

INTEGRATE has a central role in this study, working with a clinical trials unit to coordinate patient recruitment from approximately 75 UK hospitals. Each hospital will need a trainee Associate Principal Investigator and a consultant Principal Investigator, with patient recruitment and data collection led by the trainee. As an NIHR Portfolio study, trainees will be fully supported, and the Clinical Trials Unit will guide investigators through the registration and delivery stages. Data collection has been designed be straightforward, utilising patient-reported questionnaires and pure-tone and speech audiometry.

Benefits to trainees

Once funding is finalised, the trial will become part of the NIHR portfolio, and pending approval, any trainee providing site leadership will:

  • Be awarded NIHR Associate Principal Investigator status and a certificate
  • Be included in collaborative authorship in the primary publication(s)
  • Gain research and clinical training
  • Develop a greater understanding of the role of a Principal Investigator in clinical research

Benefits to consultants

The trial will become part of the NIHR Portfolio, and pending approval, any consultant providing site leadership will: 

  • Be included in collaborative authorship in the primary publication(s)
  • Gain expertise in intratympanic steroid delivery if this is not currently used in your usual clinical practice
  • Contribute to one of the largest collaborative trials in ENT in terms of site numbers

Register your interest

***Trainees register here***
***Consultants register here***

Currently, we are only looking for trainees and consultants to register their interest using the links above. We ask that trainees discuss the trial with a local supervising consultant, and provide contact details for at least one trainee and consultant per hospital. Following funding being finalised, centres will not open to recruitment until early 2022,, and we appreciate you may not be working your current Trust, or even as a trainee. At this point we only need to build a database of interested individuals, and site/consultant pairings can be reassigned as needed. For this reason, we also welcome multiple applications from the same hospital.

Please note that signing up now does not confirm or commit you, your consultant or site to participating.

We look forward to working together on this exciting trial!

Matthew Smith
Co-Chief Investigator, INTEGRATE outgoing Chair, ENT Senior Fellow

James Tysome
Co-Chief Investigator, Consultant ENT and skull base surgeon

Interested sites

The following sites have already expressed an interest in taking part: