Video Game Hearing Tests for Remote Monitoring of Ototoxicity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Validation of the Use of Video Games and Virtual Reality to Enable Autonomous Remote Monitoring of OTotoxicity in High-risk Population Groups.

Conditions
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Aminoglycoside Toxicity, Aminoglycoside-Induced Hearing Loss, Hearing Loss, Video Games

Intervention / Treatment
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* Other: video game hearing tests
* Other: Audio-training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring of ototoxicity<br>Video game hearing tests will be used to determine if they can effectively monitor changes in hearing function over time remotely. | Other: video game hearing tests<br>* Video game hearing tests (as a non-medical device) used to monitor ototoxicity<br>* Other names: Spatial Speech in Noise-Virtual Reality;|
| No Intervention: Tablet-based audiometry validation<br>Further validation of tablet-based audiometry compared to formal sound-booth audiometry. | |
| Experimental: Audio-training - intervention arm<br>Audio-training with video game hearing tests will be used to determine if it can improve spatial hearing perception. | Other: Audio-training<br>* Audio-training (as a non-medical device) used to determine if it can improve spatial hearing perception.<br>* Other names: Spatial Speech in Noise and Localisation Training;|
| No Intervention: Audio-training - control arm<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry. |  | For the 4 months that patient is enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of spatial speech in noise scores from video game-based virtual reality hearing tests. |  | 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. |  | 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. |  | For the 4 months that patient is enrolled | 
| Logistical regression modelling to determine risk factors for developing hearing loss |  | 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. | For the 4 months that patient is enrolled | 
| Pearsons correlation will be used to identify if demographic variables have an effect on questionnaire results. |  | For the 4 months that patient is enrolled |