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Completed

NCT Number: NCT03316287

Big Data Supporting Public Health Hearing Policies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guy's and St. Thomas' Foundation Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hearing Aid

Device

Smart hearing aid to allow collection of real time hearing aid usage data

mobile phone

Device

Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests

Sensor

Device

Wearable biosensor for the collection of physiological data

Primary outcomes

  1. Change in "Glasgow Hearing Aid Benefit Profile" at 8 weeks

    Time frame: Baseline (i.e. before the patient receives a hearing-aid) and at 8 weeks after receiving a hearing-aid

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Acronym: EVOTION

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2017
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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