Trials / Unknown
UnknownNCT05847556
Video Game Hearing Tests for Remote Monitoring of Ototoxicity
Development and Validation of the Use of Video Games and Virtual Reality to Enable Autonomous Remote Monitoring of OTotoxicity in High-risk Population Groups.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Imperial College London · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | video game hearing tests | Video game hearing tests (as a non-medical device) used to monitor ototoxicity |
| OTHER | Audio-training | Audio-training (as a non-medical device) used to determine if it can improve spatial hearing perception. |
Timeline
- Start date
- 2022-03-16
- Primary completion
- 2023-09-15
- Completion
- 2023-09-15
- First posted
- 2023-05-06
- Last updated
- 2023-05-12
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05847556. Inclusion in this directory is not an endorsement.