Aminoglycoside ToxicityVAROTNCT05847556
Video Game Hearing Tests for Remote Monitoring of Ototoxicity
A study testing video game hearing tests and Audio-training in people with Aminoglycoside Toxicity and Aminoglycoside-Induced Hearing Loss, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
The reason for this clinical trial is to test different ways of carrying out hearing tests to be able to detect for hearing loss within the hospital and at home. 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aminoglycoside Toxicity, Aminoglycoside-Induced Hearing Loss, Hearing Loss
- What is being tested?
- video game hearing tests and Audio-training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Mar 2022to 15 Sep 2023
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients ≥16 years old intended to receive >1 day of an ototoxic agent (Pathway 1)
- All patients ≥16 years old (Pathways 2 and 3)
- Able to provide informed consent to participate in study (written and witnessed).
Who cannot join
- Inability of patient to provide informed consent.
- Patients with previous diagnosed visual impairment that cannot be corrected with glasses.
- Inability to attend audiology appointments due to state of health.
- Pregnant women.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Guy's & St Thomas' NHS Foundation Trust
London, sw3 6NP
Jamie Cheong, +442073528121, j.cheong@rbht.nhs.uk
- Recruiting
University Hospitals Dorset NHS Foundation Trust
Poole, BH15 2JB
Emma King, emmabarker@doctors.org.uk
About this study
Official title: Development and Validation of the Use of Video Games and Virtual Reality to Enable Autonomous Remote Monitoring of OTotoxicity in High-risk Population Groups.
The reason for this clinical trial is to test different ways of carrying out hearing tests to be able to detect for hearing loss within the hospital and at home.
Pathway 1:
Read more
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.
Read the detailed description
Aminoglycoside antibiotics are widely used in clinical practice to treat life-threatening infections. However, they are associated with ototoxicity leading to hearing loss, tinnitus and vestibular problems.
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.
- Being tested
- video game hearing tests, Audio-training
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video game hearing testsOther
Also called SSIN-VR, Spatial Speech in Noise-Virtual Reality
Video game hearing tests (as a non-medical device) used to monitor ototoxicity
Audio-trainingOther
Also called SSIN-Loc training, Spatial Speech in Noise and Localisation Training
Audio-training (as a non-medical device) used to determine if it can improve spatial hearing perception.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of ototoxicity | Experimental | Video game hearing tests will be used to determine if they can effectively monitor changes in hearing function over time remotely. Receives: Other: video game hearing tests |
| Tablet-based audiometry validation | No intervention | Further validation of tablet-based audiometry compared to formal sound-booth audiometry. |
| Audio-training - intervention arm | Experimental | Audio-training with video game hearing tests will be used to determine if it can improve spatial hearing perception. Receives: Other: Audio-training |
| Audio-training - control arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry.
Measured: For the 4 months that patient is enrolled
Secondary outcomes (6)
Analysis of spatial speech in noise scores from video game-based virtual reality hearing tests.
Measured: For the 4 months that patient is enrolled
Interclass correlation coefficient (ICC) with a 95% confidence interval will be used as a measure of reliability.
Measured: For the 4 months that patient is enrolled
Sensitivity, specificity and negative predictive value will be analysed to determine utility of video game-based virtual reality and tablet-based audiometry.
Measured: For the 4 months that patient is enrolled
Logistical regression modelling to determine risk factors for developing hearing loss
Measured: For the 4 months that patient is enrolled
7-point Likert scale questionnaires will be used to evaluate patient satisfaction of video game-based virtual reality hearing tests, audio-training, tablet-based and formal audiometry.
Attractiveness, perspicuity, efficiency, dependability, simulation and novelty will be interpreted and scaled from -3 (minimum) to +3 (maximum). Scores above +1 indicate a positive impression and values below -1, a negative impression.
Measured: For the 4 months that patient is enrolled
Pearsons correlation will be used to identify if demographic variables have an effect on questionnaire results.
Measured: For the 4 months that patient is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start16 Mar 2022
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aminoglycoside ToxicityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pathway 1: pilot study of non-medical device Pathway 2: observational cohort study of medical device Pathway 3: randomised pilot study of non-medical device
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anand Shah, Principal investigator, Imperial College LondonFrancis Drobniewski, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847556
- Sponsor's protocol ID
- 21HH7217
- Acronym
- VAROT
- Status last verified
- May 2023
- First submitted
- 7 Mar 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32409613Cheong 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.
PubMed 40404318
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Use of Video Games and Virtual Reality to Enable Autonomous Remote Monitoring of OTotoxicity in High-risk Population Groups.
- ClinicalTrials.gov ID
- NCT05847556
- Acronym / sponsor ID
- VAROT / 21HH7217
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 6 May 2023 (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.
The reason for this clinical trial is to test different ways of carrying out hearing tests to be able to detect for hearing loss within the hospital and at home.
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.
Detailed description
Aminoglycoside antibiotics are widely used in clinical practice to treat life-threatening infections. However, they are associated with ototoxicity leading to hearing loss, tinnitus and vestibular problems.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Pathway 1: pilot study of non-medical device Pathway 2: observational cohort study of medical device Pathway 3: randomised pilot study of non-medical device
| Arm | Type | Receives |
|---|---|---|
| Monitoring of ototoxicity | Experimental | Other: video game hearing testsVideo game hearing tests will be used to determine if they can effectively monitor changes in hearing function over time remotely. |
| Tablet-based audiometry validation | No intervention | –Further validation of tablet-based audiometry compared to formal sound-booth audiometry. |
| Audio-training - intervention arm | Experimental | Other: Audio-trainingAudio-training with video game hearing tests will be used to determine if it can improve spatial hearing perception. |
| Audio-training - control arm | No intervention | –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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients ≥16 years old intended to receive >1 day of an ototoxic agent (Pathway 1)
- All patients ≥16 years old (Pathways 2 and 3)
- Able to provide informed consent to participate in study (written and witnessed).
Key exclusion criteria (4 listed)
- Inability of patient to provide informed consent.
- Patients with previous diagnosed visual impairment that cannot be corrected with glasses.
- Inability to attend audiology appointments due to state of health.
- Pregnant women.
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 |
|---|---|---|
| video game hearing testsAlso: SSIN-VR, Spatial Speech in Noise-Virtual RealityVideo game hearing tests (as a non-medical device) used to monitor ototoxicity | Other | Monitoring of ototoxicity |
| Audio-trainingAlso: SSIN-Loc training, Spatial Speech in Noise and Localisation TrainingAudio-training (as a non-medical device) used to determine if it can improve spatial hearing perception. | Other | Audio-training - intervention arm |
Primary outcome
Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry.
Time frame: For the 4 months that patient is enrolled
6 secondary outcomes
Analysis of spatial speech in noise scores from video game-based virtual reality hearing tests.
Time frame: For the 4 months that patient is enrolled
Interclass correlation coefficient (ICC) with a 95% confidence interval will be used as a measure of reliability.
Time frame: For the 4 months that patient is enrolled
Sensitivity, specificity and negative predictive value will be analysed to determine utility of video game-based virtual reality and tablet-based audiometry.
Time frame: For the 4 months that patient is enrolled
Logistical regression modelling to determine risk factors for developing hearing loss
Time frame: For the 4 months that patient is enrolled
7-point Likert scale questionnaires will be used to evaluate patient satisfaction of video game-based virtual reality hearing tests, audio-training, tablet-based and formal audiometry.
Time frame: For the 4 months that patient is enrolled
Pearsons correlation will be used to identify if demographic variables have an effect on questionnaire results.
Time frame: For the 4 months that patient is enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 32409613Vijayasingam 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.
- Derived from this study: PubMed 40404318Cheong 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.
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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.
Anand Shah principal investigator
Imperial College London
Francis Drobniewski study chair
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video game hearing tests and Audio-training in people with Aminoglycoside Toxicity and Aminoglycoside-Induced Hearing Loss, run by Imperial College London at 2 sites 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Cheong (+442073528121, j.cheong@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry. (time frame: For the 4 months that patient is enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847556, which also lists 2 linked publications.
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 12 May 2023.