Hearing Loss, ConductiveNCT06256081
Testing a New App for Children With Glue Ear
A study testing Hear Glue ear application in people with Hearing Loss, Conductive, run by Dr. Tamsin Brown at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Conductive
- What is being tested?
- Hear Glue ear application
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- permanent hearing loss
- English not a dominant language (since the app is written in English)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridgshire Community Services NHS Trust
Cambridge, Cambridgshire, CB1 3DF
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss, Conductive
- Being tested
- Hear Glue ear application
- Keywords
- glue ear
- Medical subject headings
- Hearing Loss, Conductive, Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hear Glue ear applicationDevice
Also called headphones used with the hearing screening game on the 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.
| Study group | Role | What they receive |
|---|---|---|
| Children with hearing loss secondary to glue ear | Active comparator | 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) Receives: Device: Hear Glue ear application |
| Children with normal hearing | Sham comparator | 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. Receives: Device: Hear Glue ear application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (2)
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.
Measured: 1 hour maximum. one appointmnet where the researcher observes the child accessing the app
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
Measured: 1 hour. one appointmnet where the researcher observes the child accessing the app
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Feb 2019
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, ConductiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Teal of an app
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Tamsin Brown
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Tamsin Brown, Cambridgeshire Community Services NHS Trust
- Investigators
- Tamsin Holland Brown, MBBS, Principal investigator, Cambridgeshire Community Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256081
- Sponsor's protocol ID
- 262154
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Hear Glue Ear Software Application on Patients With Glue Ear
- ClinicalTrials.gov ID
- NCT06256081
- Acronym / sponsor ID
- 262154
- Conditions
- Hearing Loss, Conductive
- Keywords
- glue ear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Tamsin BrownUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Teal of an app
| Arm | Type | Receives |
|---|---|---|
| Children with hearing loss secondary to glue ear | Active comparator | Device: Hear Glue ear applicationChildren 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) |
| Children with normal hearing | Sham comparator | Device: Hear Glue ear applicationChildren 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. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- permanent hearing loss
- English not a dominant language (since the app is written in English)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hear Glue ear applicationAlso: headphones used with the hearing screening game on the applicationHear 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. | Device | Children with hearing loss secondary to glue ear, Children with normal hearing |
Primary outcome
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
2 secondary outcomes
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
Ease of use of the Hear Glue ear application
Time frame: 1 hour. one appointmnet where the researcher observes the child accessing the app
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Website used to give information about study outcomes to participantsLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamsin Holland Brown, MBBS principal investigator
Cambridgeshire Community Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hear Glue ear application in people with Hearing Loss, Conductive, run by Dr. Tamsin Brown at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.