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OpenTrials
Completed

NCT Number: NCT06256081

Testing a New App for Children With Glue Ear

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.

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Key information

Conditions

Hearing Loss, Conductive Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otitis Otitis Media Otitis Media with Effusion Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridgshire Community Services NHS Trust

Cambridge, Cambridgshire, CB1 3DF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hear Glue ear application

Device

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.

Other names: headphones used with the hearing screening game on the application

Primary outcomes

  1. acceptability of the Hear Glue Ear application to children with glue ear and their families

    Time frame: 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 outcomes

  1. does the hearing screen on the Hear Glue Ear application compare to hearing test results from formal audiology testing.

    Time frame: 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.

  2. Ease of use of the Hear Glue ear application

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dr. Tamsin Brown

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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