Development and Validation of the Use of Video Games and Virtual Reality to Enable Autonomous Remote Monitoring of OTotoxicity in High-risk Population Groups.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry.
时间窗: For the 4 months that patient is enrolled
次要结局
- 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.(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)