EVidenced Based Management of Hearing Impairments: Public Health pΟlicy Making Based on Fusing Big Data Analytics and simulaTION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- Change in "Glasgow Hearing Aid Benefit Profile" at 8 weeks
研究概览
简要总结
Hearing Loss (HL) affects over 5% of the world's population (WHO 2014) and is the 5th leading cause of Years Lived with Disability. HL is currently managed with Hearing Aids (HAs), i.e. programmable sound amplification devices that are worn by the hearing impaired subjects to address their hearing difficulties. HA use however is often problematic, costly and with poor overall benefits. The holistic management of HL requires appropriate public health policies for HL prevention, early diagnosis, long-term treatment and rehabilitation; detection and prevention of cognitive decline; and socioeconomic inclusion of HL patients. Currently the evidential basis for forming such policies is limited.
The EVOTION project proposes to address this by collecting and analysing a big set of heterogeneous data, including HA usage, audiological, physiological, cognitive, clinical and medication, personal, behavioural, life style, occupational and environmental data.
This will be done by:
i. accessing big datasets of existing HA user data from the EVOTION clinical partners (UCL/UCLH and GST in the UK; OTICON in Denmark) ii. collection of prospective HA user data who will be recruited to the prospective EVOTION study and who will undergo some additional assessments iii. collection of real time dynamic data of the human participant HA users who will be given a smart phone with different apps (auditory tests; auditory training), sensors (recording of heart rate, blood pressure, respiratory rate etc.) and smart HAs (recording environmental factors such as noise levels, type of noise etc.) so that real life contextual factors that affect HA usage and outcome can be identified.
These data will be analysed with big data analysis/data mining techniques in order to identify relationships between these in order to use this information to derive and support public health decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Basic understanding of oral and written English
- •Unilateral and/or bilateral mild to severe sensorineural hearing loss
- •Willing to use smart hearing aids for at least 2 hours daily on average
- •Willing/capable to use a mobile phone
排除标准
- •Dementia (MoCA<22 )
- •Not agreeing or able to attend for f/u appointments
- •Not agreeing or able to use HA >2 hours daily (average)
- •Not sufficient vision to use smartphone ap
结局指标
主要结局
Change in "Glasgow Hearing Aid Benefit Profile" at 8 weeks
时间窗: Baseline (i.e. before the patient receives a hearing-aid) and at 8 weeks after receiving a hearing-aid
次要结局
未报告次要终点
