Testing a New App for Children With Glue Ear

NCT06256081 | Completed

• 1 other identifier: 262154
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss, Conductive

Keywords

glue ear

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  1 hour maximum. one appointmnet where the researcher observes the child accessing the app

• Ease of use of the Hear Glue ear application

  1 hour. one appointmnet where the researcher observes the child accessing the app

Study Arms (2)

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)

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.

Device: Hear Glue ear application

Interventions

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.

Also known as: headphones used with the hearing screening game on the application

Children with hearing loss secondary to glue ear; Children with normal hearing

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• permanent hearing loss
• English not a dominant language (since the app is written in English)

Sponsors & Collaborators

• Dr. Tamsin Brown: lead

Study Sites (1)

Cambridgshire Community Services NHS Trust

Cambridge, Cambridgshire, CB1 3DF, United Kingdom

Location

Related Links

• Website used to give information about study outcomes to participants

MeSH Terms

Conditions

Hearing Loss, Conductive; Otitis Media with Effusion

Condition Hierarchy (Ancestors)

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

Study Officials

• Tamsin Holland Brown, MBBS

  Cambridgeshire Community Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Single arm study of children trialling an app
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Teal of an app

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 13, 2024
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)