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
1 other identifier
interventional
1,080
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedMarch 26, 2020
March 1, 2020
9 months
October 10, 2017
March 25, 2020
Conditions
Outcome Measures
Primary Outcomes (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
Study Arms (2)
Hearing aid + mobile phone
EXPERIMENTALHearing aid + mobile phone + biosensor
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guy's and St. Thomas' Foundation Trust
London, United Kingdom
Related Publications (1)
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.
PMID: 29449298DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2017
First Posted
October 20, 2017
Study Start
March 1, 2018
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
March 26, 2020
Record last verified: 2020-03