Testing a New App for Children With Glue Ear
February 5, 2024 updated by: Dr. Tamsin Brown
Testing the Hear Glue Ear Software Application on Patients 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Cambridgshire
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Cambridge, Cambridgshire, United Kingdom, CB1 3DF
- Cambridgshire Community Services NHS Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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)
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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:
|
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Sham Comparator: 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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Questionnaire: Whether children like the Hear Glue ear app and find it useful
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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.
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1 hour maximum. one appointmnet where the researcher observes the child accessing the app
|
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Ease of use of the Hear Glue ear application
Time Frame: 1 hour. one appointmnet where the researcher observes the child accessing the app
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Questionnaire and Number of mistakes: Can children easily access the Hear Glue Ear application without help from an adult
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1 hour. one appointmnet where the researcher observes the child accessing the app
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tamsin Holland Brown, MBBS, Cambridgeshire Community Services
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
February 25, 2019
First Submitted That Met QC Criteria
February 5, 2024
First Posted (Actual)
February 13, 2024
Study Record Updates
Last Update Posted (Actual)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 262154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All patient data will only be held by the small research team gathering data for this project.
Data will be held in line with GDPR and ethical approval.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.