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Big Data Supporting Public Health Hearing Policies

EVidenced Based Management of Hearing Impairments: Public Health pΟlicy Making Based on Fusing Big Data Analytics and simulaTION

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03316287
Acronym
EVOTION
Enrollment
1080
Registered
2017-10-20
Start date
2018-03-01
Completion date
2018-11-30
Last updated
2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Brief summary

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.

Interventions

DEVICEHearing aid

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

DEVICESensor

Wearable biosensor for the collection of physiological data

Sponsors

University College, London
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in Glasgow Hearing Aid Benefit Profile at 8 weeksBaseline (i.e. before the patient receives a hearing-aid) and at 8 weeks after receiving a hearing-aid

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026