The SeaSHeL National Prospective Cohort Study
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)
Links
- Source: http://clinicaltrials.gov/show/NCT04108598
- ClinicalTrials.gov processed this data on October 02, 2019
Published on BioPortfolio: 2019-10-03T07:54:39-0400
Clinical Trials
Audiology Visits After Screening for Hearing Loss: An RCT
Hearing impairment is one of the most common disabilities in veterans. The decreased ability to communicate is troubling in itself, but the strong association of hearing loss with functio...
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed ...
Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localiz...
Communities Helping the Hearing of Infants by Reaching Parents
Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests ...
Quality Control of CE-Certified Phonak Hearing Aids - 2016_37
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. ...
PubMed Articles
Considering that hearing loss has a significant impact on social functioning, everyday activity and a person's emotional state, one of the most important goals of hearing rehabilitation with bone cond...
To compare the quality of life (QoL) of children with hearing loss (HL) and children with normal hearing (NH) and to examine how the QoL of children with HL changes over time, considering language ski...
What is noise-induced hearing loss?
Noise-induced hearing loss is sensory deafness caused by long-term exposure of the auditory system to a noisy environment. Auditory fatigue is an early symptom of noise-induced hearing loss, and heari...
Hearing loss (HL) is the most common sensory-neural disorder with excessive clinical and genetic heterogeneity, which negatively affects life quality. Autosomal recessive non-syndromic hearing loss (A...
To investigate the associations of hearing thresholds and slight to mild hearing loss with academic, behavioural and quality of life outcomes in children at a population level.
Medical and Biotech [MESH] Definitions
Hearing Loss, Noise-induced
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, Central
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, Mixed Conductive-sensorineural
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, Functional
Hearing loss without a physical basis. Often observed in patients with psychological or behavioral disorders.
Hearing Loss, High-frequency
Hearing loss in frequencies above 1000 hertz.
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