Video Game Hearing Tests for Remote Monitoring of Ototoxicity
NCT ID: NCT05847556
Last Updated: 2023-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2022-03-16
2023-09-15
Brief Summary
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Pathway 1:
The goal of this clinical trial is to learn whether video game hearing tests work well to detect hearing loss caused by antibiotics at home in patients with long-term lung infections.
Pathway 2:
The goal of this clinical trial is to compare tablet-based (iPad) hearing tests with formal sound booth hearing tests in patients attending hospital outpatient clinics.
Pathway 3:
The goal of this clinical trial is to learn whether audio-training improves listening to speech in the presence of background noise. Researchers will compare participants receiving audio-training with those who did not receive audio-training. This will test if audio-training can improve participant's everyday listening experiences.
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Detailed Description
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Mobile devices such as tablet audiometry have recently been validated as a screening tool for hearing loss in an adult cystic fibrosis cohort demonstrating good sensitivity, specificity and positive predictive value when compared to formal sound booth audiometry (Vijayasingam 2020).
Technology from the BEARS project is being adapted to integrate hearing tests within video games and virtual reality software. This technology (Spatial Speech in Noise virtual reality (SSIN-VR) test) will then be used as a tool to perform hearing tests to see if it can detect ototoxicity in adult patients receiving ototoxic agents. The video game-based virtual reality technology (Spatial Speech in Noise and Localisation (SSIN-Loc Training)) will be used to train and potentially improve spatial hearing. This can be done remotely at the convenience of the patient and aims to be an effective way of monitoring hearing autonomously with high usability.
There are 3 pathways within this study:
Pathway 1 (monitoring ototoxicity) is a pilot study to measure the utility and effectiveness of video game-based virtual reality (SSIN-VR) hearing tests as an effective means to monitor hearing loss in patients receiving ototoxic agents. It will be compared with tablet-based audiometry carried out by non-specialist staff, and formal standard sound-booth extended high-frequency audiometry performed by an audiologist. 30 patients receiving an ototoxic agent, presenting at one of the recruiting centres, will be recruited into this pathway.
Pathway 2 is a prospective observational cohort study which continues to validate the use of tablet-based audiometry compared with formal standard sound-booth extended high-frequency audiometry performed by an audiologist. 80 patients, presenting at one of the recruiting centres, will be prospectively recruited into this pathway.
Pathway 3 is a pilot study which assesses whether audio-training (SSIN-Loc training) with video game-based virtual reality (SSIN-VR) hearing tests can improve spatial hearing perception and speech intelligibility. 30 participants will be recruited into this pathway. They will be randomised to either the intervention group (Arm 1) or the control group (Arm 2). All participants will carry out a baseline video game-based virtual reality hearing (SSIN-VR) test in the first week.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Monitoring of ototoxicity
Video game hearing tests will be used to determine if they can effectively monitor changes in hearing function over time remotely.
video game hearing tests
Video game hearing tests (as a non-medical device) used to monitor ototoxicity
Tablet-based audiometry validation
Further validation of tablet-based audiometry compared to formal sound-booth audiometry.
No interventions assigned to this group
Audio-training - intervention arm
Audio-training with video game hearing tests will be used to determine if it can improve spatial hearing perception.
Audio-training
Audio-training (as a non-medical device) used to determine if it can improve spatial hearing perception.
Audio-training - control arm
No audio-training but video game hearing tests will be used as a comparator arm to identify if audio-training can improve spatial hearing perception.
No interventions assigned to this group
Interventions
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video game hearing tests
Video game hearing tests (as a non-medical device) used to monitor ototoxicity
Audio-training
Audio-training (as a non-medical device) used to determine if it can improve spatial hearing perception.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients ≥16 years old (Pathways 2 and 3)
* Able to provide informed consent to participate in study (written and witnessed).
Exclusion Criteria
* Patients with previous diagnosed visual impairment that cannot be corrected with glasses.
* Inability to attend audiology appointments due to state of health.
* Pregnant women.
16 Years
ALL
Yes
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Anand Shah
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Francis Drobniewski
Role: STUDY_CHAIR
Imperial College London
Locations
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Guy's & St Thomas' NHS Foundation Trust
London, , United Kingdom
University Hospitals Dorset NHS Foundation Trust
Poole, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Vijayasingam A, Frost E, Wilkins J, Gillen L, Premachandra P, Mclaren K, Gilmartin D, Picinali L, Vidal-Diez A, Borsci S, Ni MZ, Tang WY, Morris-Rosendahl D, Harcourt J, Elston C, Simmonds NJ, Shah A. Tablet and web-based audiometry to screen for hearing loss in adults with cystic fibrosis. Thorax. 2020 Aug;75(8):632-639. doi: 10.1136/thoraxjnl-2019-214177. Epub 2020 May 14.
Cheong J, Lowe E, Lee CW, Barbosa C, Gillen L, King E, Premachandra P, Shah A, Drobniewski F. Globally applicable solution to hearing loss screening: a diagnostic accuracy study of tablet-based audiometry. BMJ Open. 2025 May 22;15(5):e097550. doi: 10.1136/bmjopen-2024-097550.
Other Identifiers
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21HH7217
Identifier Type: -
Identifier Source: org_study_id
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