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The SeaSHeL National Prospective Cohort Study

2019-10-03 07:54:39 | BioPortfolio

Summary

Each year, approximately 15,000 people in the United Kingdom experience sudden loss of hearing. Of those who present to the NHS, the cause is unknown in most cases despite investigation, and these cases are termed idiopathic 'sudden onset sensorineural hearing loss' (SSNHL). Treatment options for idiopathic SSNHL mainly include steroid treatments and their efficacy is not well known.

There are a number of new treatments being developed for SSNHL based upon recent discoveries regarding factors causing the condition. These treatments require rigorous testing in clinical trials before they can become available for clinical use. To allow for such trials to be run there is an urgent need for information on patient numbers and characteristics, geographical distribution, patient and treatment pathways, as well as outcomes. There is an urgent need to understand this patient population to help develop new treatments.

The investigators will record routinely collected information of patients presenting with SSNHL (including: patient characteristics, treatment received, hearing levels). This will take place at 97 National Health Services (NHS) sites across the country with Ear, Nose, and Throat (ENT) and Audiology services. 20 of these sites will also collect quality of life information via questionnaires.

Once the data has been collected, it will be analysed to:

1. Establish the patient pathway for patients presenting with SSNHL in the NHS

2. Develop a tool that will help predict recovery for patients with SSNHL.

3. Establish the impact of SSNHL on people's quality of life.

Description

Brief background Currently there is insufficient evidence about the patient pathway and hearing outcomes of patients presenting with SSNHL in the NHS.

Based on recent discoveries in the molecular mechanisms that lead to SSNHL, new therapeutics are being developed that are ready for trialing.

To allow for these trials to be run effectively and reliably within the NHS, information on where and when patients with idiopathic SSNHL present and how they fare needs to be known.

Objectives

1. To map the patient pathway and identify the characteristics of adult patients presenting to NHS ENT and hearing services with SSNHL.

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

3. Establish the impact of idiopathic SSNHL on patients' quality of life

Methods Study design: National multicentre prospective observational cohort study across 97 trusts.

Inclusion/Exclusion criteria: Adult patients with idiopathic SSNHL presenting to the NHS Data collection: Using REDCap, patient demographics, geographical distribution, treatment pathways and outcomes will be recorded. A selection of these sites (n=20) will collect patient quality of life data.

Analysis: A multivariable prognostic model will be created to predict recovery for patients with SSNHL.

Study Design

Conditions

Sensory Hearing Loss

Intervention

Quality of life questionnaire

Location

UCL
London
United Kingdom

Status

Enrolling by invitation

Source

University College, London

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-03T07:54:39-0400

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Medical and Biotech [MESH] Definitions

Hearing loss due to exposure to explosive loud noise or chronic exposure to sound level greater than 85 dB. The hearing loss is often in the frequency range 4000-6000 hertz.

Hearing loss due to disease of the AUDITORY PATHWAYS (in the CENTRAL NERVOUS SYSTEM) which originate in the COCHLEAR NUCLEI of the PONS and then ascend bilaterally to the MIDBRAIN, the THALAMUS, and then the AUDITORY CORTEX in the TEMPORAL LOBE. Bilateral lesions of the auditory pathways are usually required to cause central hearing loss. Cortical deafness refers to loss of hearing due to bilateral auditory cortex lesions. Unilateral BRAIN STEM lesions involving the cochlear nuclei may result in unilateral hearing loss.

Hearing loss due to damage or impairment of both the conductive elements (HEARING LOSS, CONDUCTIVE) and the sensorineural elements (HEARING LOSS, SENSORINEURAL) of the ear.

Hearing loss without a physical basis. Often observed in patients with psychological or behavioral disorders.

Hearing loss in frequencies above 1000 hertz.

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