EVOTION: Big Data Supporting Public Health Hearing Policies

Sponsor
University College, London (Other)
Overall Status
Completed
CT.gov ID
NCT03316287
Collaborator
(none)
1,080
1
2
9
120

Study Details

Study Description

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:
  1. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hearing aid
  • Device: Mobile phone
  • Device: Sensor
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1080 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
EVidenced Based Management of Hearing Impairments: Public Health pΟlicy Making Based on Fusing Big Data Analytics and simulaTION
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Nov 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hearing aid + mobile phone

Device: Hearing aid
Smart hearing aid to allow collection of real time hearing aid usage data

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

Experimental: Hearing aid + mobile phone + biosensor

Device: Hearing aid
Smart hearing aid to allow collection of real time hearing aid usage data

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

Device: Sensor
Wearable biosensor for the collection of physiological data

Outcome Measures

Primary Outcome Measures

  1. Change in "Glasgow Hearing Aid Benefit Profile" at 8 weeks [Baseline (i.e. before the patient receives a hearing-aid) and at 8 weeks after receiving a hearing-aid]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guy's and St. Thomas' Foundation Trust London United Kingdom

Sponsors and Collaborators

  • University College, London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College, London
ClinicalTrials.gov Identifier:
NCT03316287
Other Study ID Numbers:
  • 17/0064
First Posted:
Oct 20, 2017
Last Update Posted:
Mar 26, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 26, 2020