Assessing a new test of the ear in children
Research type
Research Study
Full title
Defining Normative Data and Test-Retest Reliability in Children Aged 4-12 years using Wideband Tympanometry.
IRAS ID
215478
Contact name
John E FitzGerald
Contact email
Sponsor organisation
Norfolk and Norwich University Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 8 months, 15 days
Research summary
There is a high incidence of middle ear dysfunction in children. Glue ear (fluid in the middle ear) is particularly common: it is estimated that 80% children will have had at least one episode by age 10.
Tympanometry, a common test of middle ear function (listed as part of the NICE guidelines for glue ear diagnosis (nice.org.uk/guidance/cg60)) uses a single sound pitch, across a pressure range, but is of limited help in specific diagnosis of some middle ear conditions.
Wideband Tympanometry (WBT) is a modern version which delivers a wide-band sound signal, encompassing a wide range of sound pitches. Since this provides much more information about the middle ear, it may allow greater differentiation of middle ear disorders, thereby helping in faster, more efficient diagnosis of patients, and more effective treatment as a result.
WBT is still somewhat new, particularly in clinical settings, and paediatric data is sparse. This study aims to define what “normal” WBT responses are in children aged 4-12. In particular, it aims to see if the response changes with age, and assess how it varies between patients. Additionally, it aims to address how reliable the test is when repeated for the same patient, and when carried out by different testers.
The study will be conducted at the Norfolk and Norwich University hospital, and will be offered to patients in standard Audiology clinics with normal hearing, as determined by our routine clinical testing. Like normal tympanometry, an earpiece i placed in the ear and a sound presented across a pressure range. This takes 5-10 seconds, and 3 results will be obtained per normal ear.
Establishing normal WBT responses will allow further studies into specific ear conditions, with the ultimate aim to use WBT in routine clinical settings.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
16/EM/0516
Date of REC Opinion
15 Dec 2016
REC opinion
Favourable Opinion