The SeaSHeL project

Prognostic factors for outcomes of idiopathic Sudden onset Sensorineural Hearing Loss: the SeaSHeL national prospective cohort study

 

AIM

To develop a prediction model to predict recovery for patients with SSNHL.

 

Setting

A multicentre study taking place at NHS centres providing ENT and Hearing Services.

 

Inclusion criteria

  • Adult patients (male or female) aged over 16 years of age presenting to NHS ENT and hearing services with SSNHL

AND

  • Diagnosed with a hearing loss in one or both ears of 30 dB HL or more, over at least 3 contiguous frequencies, between 250, 500, 1000, 2000, 4000 and 8000 Hz.

AND

  • Willing and able to provide written informed consent.

 

Exclusion criteria

  • Patients with mixed or conductive hearing loss (CHL). CHL will be defined as a ‘true’ air-bone gap of 15 dB HL or more in 3 or more contiguous frequencies between 500, 1000, 2000, 4000

 

Progress so far:

-The NHS Ethics form has been submitted, with proportionate ethics review on the 28th August.

-We have secured funding from SENSORION

-NIHR CRN have agreed to support the study

-The REDCap data collection sheet and REDCap step-by-step guide have been prepared.

-Information packs for Regional Leads have been prepared

-We have so far secured 12 Regional leads. We are still looking for Leads in the following 3 regions: Yorkshire and Humber, Oxford, South East England.

 

Next Steps:

-Secure remaining Regional lead positions

We are awaiting REDCap logins for all regions from UCL

-Regional leads to recruit Site Leads.

-Await ethics and HRA review

-Site Lead ‘packs’ need to be prepared and sent to all Site Leads. These packs will contain

  • Site Lead information letter
  • Step-by-step guide of what each Site Lead needs to do (including registering study locally)
  • Study protocol
  • Consent form (for QoL sites)
  • Patient information sheet (PIS) (for QoL sites)
  • QoL questionnaires (for QoL sites)
  • Paper data collection tool
  • REDCap Login details for Site Leads.
  • REDCap user guide
  • Advertisement material.

 

***We are looking for Regional Leads in Yorkshire and Humber, Oxford, South East England (1-2 in each Region)***