Testing a New App for Children With Glue Ear

Not Applicable

Completed

• Conditions: Hearing Loss, Conductive
• Interventions: Device: Hear Glue ear application

• Registration Number: NCT06256081
• Lead Sponsor: Dr. Tamsin Brown

Brief Summary

To assess whether children with glue ear ( and some normal hearing controls) and their families find the Hear Glue Ear application acceptable and easy to use. Whether the hearing screening section on the app is comparable to the hearing test data obtained from formal audiology hearing tests.

Detailed Description

The Hear Glue Ear application aims to provide up-to-date information for families as well as audiobooks, songs and games for children with hearing loss secondary to glue ear, to be able to aid with their developmental skills (particularly speech, language, auditory processing, auditory memory and listening skills) during the period of time when they have glue ear.

Outcome measures include acceptability of the application by the family (provided by questionnaires to the child and an adult parent/ carer), usability of the app (a member of the research team will observe the child using the app and how much difficulty they have such as how many times the researcher has to help/ intervene) and comparison of the hearing screen on the app with formal audiology hearing test result.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-02-25
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-31
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-05
• Last Update Submitted: 2024-02-05
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• aged 2-8 years old
• had a formal hearing test at Cambridge audiology clinic and has a diagnosis of gluem ear worse than 25dB at more than 1 frequency or nornmal hearing diagnosed where 20dB or better is recorded at 0.5, 1, 2, 4 KHz

Exclusion Criteria

• permanent hearing loss
• English not a dominant language (since the app is written in English)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with normal hearing	Hear Glue ear application	Children accessing the community audiology NHS services due to concerns about hearing loss who do not have a diagnosis of glue ear (also known as otitis media with effusion, OME) and are confirmed as having normal hearing.
Children with hearing loss secondary to glue ear	Hear Glue ear application	Children accessing the community audiology NHS services due to concerns about hearing loss who have a diagnosis of glue ear (also known as otitis media with effusion, OME)

Primary Outcome Measures

Name	Time	Method
acceptability of the Hear Glue Ear application to children with glue ear and their families	Observing the child looking at the app for he first time and following up with the family after 1 week from baseline regarding whether they used it at home	Questionnaire: Whether children like the Hear Glue ear app and find it useful

Secondary Outcome Measures

Name	Time	Method
Ease of use of the Hear Glue ear application	1 hour. one appointmnet where the researcher observes the child accessing the app	Questionnaire and Number of mistakes: Can children easily access the Hear Glue Ear application without help from an adult
does the hearing screen on the Hear Glue Ear application compare to hearing test results from formal audiology testing.	1 hour maximum. one appointmnet where the researcher observes the child accessing the app	Comparison between results: Children will have had a formal hearing test before they are invited into the study and theis will be compared to their results on the hearing screening game within the application.

Trial Locations

Locations (1)

Cambridgshire Community Services NHS Trust; 🇬🇧 Cambridge, Cambridgshire, United Kingdom