Testing a New App for Children With Glue Ear

Hearing Loss, Conductive Clinical Trial

Official title:

Testing the Hear Glue Ear Software Application on Patients With Glue Ear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06256081
• Other study ID #: 262154
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2024
• Source: Cambridgeshire Community Services NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Conductive
• Otitis Media with Effusion

Intervention

Device:
• Hear Glue ear application
Hear Glue ear is an application used on phones, ipads, tablets or computers which provides free information, songs, audiobooks, games and a home hearing screening game.

Locations

Country	Name	City	State
United Kingdom	Cambridgshire Community Services NHS Trust	Cambridge	Cambridgshire

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Tamsin Brown

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acceptability of the Hear Glue Ear application to children with glue ear and their families	Questionnaire: Whether children like the Hear Glue ear app and find it useful	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
Secondary	does the hearing screen on the Hear Glue Ear application compare to hearing test results from formal audiology testing.	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.	1 hour maximum. one appointmnet where the researcher observes the child accessing the app
Secondary	Ease of use of the Hear Glue ear application	Questionnaire and Number of mistakes: Can children easily access the Hear Glue Ear application without help from an adult	1 hour. one appointmnet where the researcher observes the child accessing the app

External Links

•   Website used to give information about study outcomes to participants