Testing a New App for Children With Glue Ear

NCT ID: NCT06256081

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Hearing Loss, Conductive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Teal of an app
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Single arm study of children trialling an app

Study Groups

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Children with hearing loss secondary to glue ear

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)

Group Type ACTIVE_COMPARATOR

Hear Glue ear application

Intervention Type 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.

Children with normal hearing

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.

Group Type SHAM_COMPARATOR

Hear Glue ear application

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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headphones used with the hearing screening game on the application

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Tamsin Brown

OTHER

Sponsor Role lead

Responsible Party

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Dr. Tamsin Brown

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tamsin Holland Brown, MBBS

Role: PRINCIPAL_INVESTIGATOR

Cambridgeshire Community Services

Locations

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Cambridgshire Community Services NHS Trust

Cambridge, Cambridgshire, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.hearglueear.Wordpress.com

Website used to give information about study outcomes to participants

Other Identifiers

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262154

Identifier Type: -

Identifier Source: org_study_id

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