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Ear Explorers: Join us for a journey inside the middle ear. A study to compare still images and videos of the middle ear to diagnose middle ear infections.

Ear Explorers: A prospective study comparing effectiveness of otoscopic still images and videos in remotely diagnosing otitis media. A Perth Children's Hospital (PCH) Ear Portal Sub-study.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001293156
Enrollment
157
Registered
2019-09-19
Start date
2019-10-26
Completion date
2019-10-30
Last updated
2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Ear Health team currently runs a number of community-based ear health epidemiology, health promotion and telehealth projects. One of the key challenges faced for these projects is having the right equipment to obtain a clear otoscopic image of an ear drum that can be interpreted remotely by specialists.. Effective telehealth programs need appropriate equipment that can provide high-quality images of the ear and be easy to use, as the staff using the equipment may be nurses or health workers with little previous experience of performing otoscopy (ear examinations). During Ear Portal visits, otoscopy is conducted remotely by assistants and transmitted via a store and send method to specialists for review. If remotely provided otoscopic images are of poor quality, the ability to make a diagnosis is hindered resulting in the need for repeat assessment and delays in provision of care. This is a prospective sub-study which is linked to the PCH Ear Portal main study. Participants will be recruited opportunistically at community events including Telethon Weekend and the Cockburn Integrated Health NAIDOC event in October 2019 . Otoscopic still images and short videos will be obtained using the HearScope. The results will be saved and stored for later review and comparison by ENT/Audiologists along with supporting screening questionnaires and tympanometry. The sub-study results will be used to inform best technique (images or video) for obtaining views of the eardrum by research assistants during the Ear Portal main study to facilitate telehealth assessment by the multidisciplinary team (MDT).

Interventions

Participants between 6 months and 15 years of age will be recruited opportunistically at Telethon Weekend and NAIDOC community events. Study staff will obtained informed consent and collect a basic screening ear health history. A trained assistant or audiologist will use the HearScope otoscope attached to a smartphone device to take still images and short 10 second videos of the middle ear and a Titan middle ear analyser to do tympanometry (a test to measure the movement of the ear drum) of each

Participants between 6 months and 15 years of age will be recruited opportunistically at Telethon Weekend and NAIDOC community events. Study staff will obtained informed consent and collect a basic screening ear health history. A trained assistant or audiologist will use the HearScope otoscope attached to a smartphone device to take still images and short 10 second videos of the middle ear and a Titan middle ear analyser to do tympanometry (a test to measure the movement of the ear drum) of each ear. The results of these tests will be saved for later comparison and analysis by a blinded consultant. If the results are abnormal and clinically significant, an audiologist will provide the family with counselling and a GP referral. Participation in the project is expected to last approximately 10-15 minutes. The sub-study will precede the main Ear Portal study, with the findings informing the otoscopic technique (image or videos) that will be used during the main study. Participants in the Ear Explorers sub-study will therefore be recruited independently to the main Ear Portal study and form a separate cohort. They will only complete the Ear Explorers one-off visit and data collection.

Sponsors

Telethon Kids Institute
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
6 Months to 15 Years
Healthy volunteers
Yes

Inclusion criteria

1. Children aged 6 months to 15 years of age 2. A parent/guardian is present to provide informed consent for the child to participate The cohort for this sub-study is separate to the main Ear Portal study; therefore participation in the main study is not an inclusion criteria.

Exclusion criteria

1. Does not have a parent/guardian present on the day. 2. Contraindications for otoscopy or tympanometry including discharging ear or recent surgery within the last 6 weeks

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026