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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Fei Zhao
+44 (0)2920417290
fzhao@cardiffmet.ac.uk


Study Location:

Noah's Ark Children's Hospital for Wales, University Hospital of Wales
Heath Park
Cardiff
CF14 4XW


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Using artificial intelligence to diagnose 'glue ear' in children

Not Recruiting

Open to: All Genders

Age: Child

Medical Conditions

Otitis media


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Background and study aims
Otitis media with effusion (OME) (also known as ‘glue ear’) is one of the most common causes of childhood hearing impairment and disability. It is estimated that more than 80% of children will have otitis media before the age of 10 years. This places a significant cost burden on the NHS with about 200,000 children with OME seen annually in primary care. Delayed diagnosis and poorly managed cases can result in severe and persistent OME with surgical treatment becoming the only management option, leading to long waiting times and excessively high costs for the NHS. Recent research into AI has made great progress in demonstrating its potential for the accurate diagnosis of OME. This novel research proves the capability of AI tools to diagnose OME automatically with an accuracy of 82%. The aim of this study is to achieve the best accuracy and reliability of these AI tools.

Who can participate?
Children under 12 years old who have been attending the clinic because parents/guardians are concerned about their hearing, or for a follow-up appointment after an acute case of ‘glue ear’.

What does this study involve?
The study involves a simple, fast, objective, and non-invasive middle ear measurement using a commercialised device called Wideband Absorbance Immittance (WAI) by Interacoustics after the patient has completed their routine hearing tests. Basically, a small probe will be placed in the patient’s ear canal, send some quiet clicks into their ear, and record the responses from the ear canal. The WAI test is performed by a clinical researcher and this procedure will be very quick (less than 1 minute per side).

What are the possible benefits and risks of participating?
The device should lead to significant and direct impacts on clinical assessment and diagnostic concepts for childhood OME in professional communities, and the NICE guidelines for childhood OME treatment. The benefits derived from its wider use as a diagnostic tool for accurate diagnosis of OME are summarised as follows. From the child development perspective, children with OME will benefit directly from prompt and accurate diagnosis and the application of appropriate management strategies tailored to support their ongoing development in areas such as speech and language development, education and future health. In this way, the potential risks on the child’s social and future development that are associated with this condition will be removed. From the parents’ perspective, early and accurate diagnosis will help minimise parental concerns regarding their child's behaviour, performance at school, or language development, particularly where GPs primarily consult for the management of ear-specific symptoms only and do not start interventions immediately. The accurate, timely, efficient, equitable and patient-centred delivery of the enhanced quality healthcare will directly increase parental satisfaction. Because the WAI test is a simple, fast, objective, and non-invasive middle ear measurement using a commercialised device by Interacoustics after the participants have completed their routine hearing assessment, there should not be any significant risks in completing this study.

Where is this study run from?
Noah’s Ark Children’s Hospital for Wales and the Child Health Centre in St David’s Hospital, Cardiff (UK)

When is the study starting and how long is it run for?
November 2020 to September 2022

Who is funding this study?
National Institute for Health Research (NIHR) (UK)

The newly developed Artificial Intelligence (AI) techniques provide an accurate and reliable automated diagnosis of childhood otitis media with effusion (OME).


Two-arm randomized parallel study

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

03 Jan 2022

30 Sep 2022

Interventional

Intervention Type : Device
Intervention Description : The study involves a simple, fast, objective, and non-invasive middle ear measurement using a commercialised device called Wideband Absorbance Immittance (WAI) by Interacoustics after the patient completed their routine hearing assessments. Basically, a small probe will be placed in the patient’s ear canal, sending some quiet clicks into their ear, and recording the responses from the ear canal. The WAI test is performed by a clinical researcher and this procedure is very quick (less than 1 minute per test).

The participants will be randomly assigned to two groups that differ according to whether clinicians take the output provided by the AI-WAI support tool into account when making decisions or not:

Group A (diagnostic decision without AI-WAI support tool): clinicians will make their diagnostic decision and subsequent management based on traditional assessments, according to The National Institute for Clinical Excellence (NICE) guideline for otitis media with effusion in under 12s: surgery (2008). They will not be informed of the test results given by the AI-WAI system.

Group B (diagnostic decision with consideration of AI-WAI output): the clinician will be informed of the outcomes provided by AI-WAI support tool. As a result, they will make the diagnostic decision by considering the AI-WAI support tool.


You can take part if:


Children under 12 years old attending the clinic due to parental concerns regarding hearing loss or for follow-up appointments after acute otitis media




You may not be able to take part if:

Children with ventilation tubes in situ


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Noah's Ark Children's Hospital for Wales, University Hospital of Wales
    Heath Park
    Cardiff
    CF14 4XW
  • St David’s Hospital
    Child Health Centre Cowbridge Road East Canton
    Cardiff
    CF11 9XB


The study is sponsored by Cardiff Metropolitan University and funded by National Institute for Health Research.



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for Trial ID: ISRCTN17082829

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