Clinical trial NCT05847556: Video Game Hearing Tests for Remote Monitoring of Ototoxicity
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aminoglycoside Toxicity
Aminoglycoside-Induced Hearing Loss
Hearing Loss
Video Games
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry.
timeFrame: For the 4 months that patient is enrolled
Secondary outcomes:
measure: Analysis of spatial speech in noise scores from video game-based virtual reality hearing tests.
timeFrame: For the 4 months that patient is enrolled
measure: Interclass correlation coefficient (ICC) with a 95% confidence interval will be used as a measure of reliability.
timeFrame: For the 4 months that patient is enrolled
measure: Sensitivity, specificity and negative predictive value will be analysed to determine utility of video game-based virtual reality and tablet-based audiometry.
timeFrame: For the 4 months that patient is enrolled
measure: Logistical regression modelling to determine risk factors for developing hearing loss
timeFrame: For the 4 months that patient is enrolled
measure: 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.
timeFrame: For the 4 months that patient is enrolled
measure: Pearsons correlation will be used to identify if demographic variables have an effect on questionnaire results.
timeFrame: For the 4 months that patient is enrolled
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
city: Poole
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust
Study officials:
affiliation: Imperial College London
name: Anand Shah
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Francis Drobniewski
role: STUDY_CHAIR
References:
citation: 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.