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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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London、イギリス
- Guy's and St. Thomas' Foundation Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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実験的: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Change in "Glasgow Hearing Aid Benefit Profile" at 8 weeks
時間枠: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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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。