The SeaSHeL project
Prognostic factors for outcomes of idiopathic Sudden onset Sensorineural Hearing Loss: the SeaSHeL national prospective cohort study
To develop a prediction model to predict recovery for patients with SSNHL.
A multicentre study taking place at NHS centres providing ENT and Hearing Services.
- Adult patients (male or female) aged over 16 years of age presenting to NHS ENT and hearing services with SSNHL
- 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.
- Willing and able to provide written informed consent.
- 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.
-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.