Testing a New App for Children With Glue Ear

Dr. Tamsin Brown

Status: Completed

Conditions: Hearing Loss, Conductive

Treatments: Device: Hear Glue ear application

Study type: Interventional

Funder types: Other

Identifiers

NCT06256081

262154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Children with hearing loss secondary to glue ear

Active Comparator group

Description:

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)

Treatment:

Device: Hear Glue ear application

Children with normal hearing

Sham Comparator group

Description:

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.

Treatment:

Device: Hear Glue ear application