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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06256081
Other study ID # 262154
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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