Big Data Supporting Public Health Hearing Policies (EVOTION)
EVidenced Based Management of Hearing Impairments: Public Health pΟlicy Making Based on Fusing Big Data Analytics and simulaTION
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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London、英国
- Guy's and St. Thomas' Foundation Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Hearing aid + mobile phone
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Smart hearing aid to allow collection of real time hearing aid usage data
Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
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实验性的:Hearing aid + mobile phone + biosensor
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Smart hearing aid to allow collection of real time hearing aid usage data
Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
Wearable biosensor for the collection of physiological data
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Change in "Glasgow Hearing Aid Benefit Profile" at 8 weeks
大体时间:Baseline (i.e. before the patient receives a hearing-aid) and at 8 weeks after receiving a hearing-aid
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Baseline (i.e. before the patient receives a hearing-aid) and at 8 weeks after receiving a hearing-aid
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Hearing aid的临床试验
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Fondazione Poliambulanza Istituto Ospedaliero完全的
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Butler HospitalBrown University; University of Rhode Island邀请报名
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D'Or Institute for Research and EducationTERGOS PESQUISA E ENSINO S.A尚未招聘