Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1080 participants
INTERVENTIONAL
2018-03-01
2018-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Hearing aid + mobile phone
Hearing aid
Smart hearing aid to allow collection of real time hearing aid usage data
Mobile phone
Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
Hearing aid + mobile phone + biosensor
Hearing aid
Smart hearing aid to allow collection of real time hearing aid usage data
Mobile phone
Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
Sensor
Wearable biosensor for the collection of physiological data
Interventions
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Hearing aid
Smart hearing aid to allow collection of real time hearing aid usage data
Mobile phone
Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
Sensor
Wearable biosensor for the collection of physiological data
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University College, London
OTHER
Responsible Party
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Locations
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Guy's and St. Thomas' Foundation Trust
London, , United Kingdom
Countries
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References
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Dritsakis G, Kikidis D, Koloutsou N, Murdin L, Bibas A, Ploumidou K, Laplante-Levesque A, Pontoppidan NH, Bamiou DE. Clinical validation of a public health policy-making platform for hearing loss (EVOTION): protocol for a big data study. BMJ Open. 2018 Feb 15;8(2):e020978. doi: 10.1136/bmjopen-2017-020978.
Other Identifiers
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17/0064
Identifier Type: -
Identifier Source: org_study_id
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