Big Data Supporting Public Health Hearing Policies (EVOTION)
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hearing aid
Mobile phone
Sensor
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
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
Sites / Locations
- Guy's and St. Thomas' Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hearing aid + mobile phone
Hearing aid + mobile phone + biosensor
Arm Description
Outcomes
Primary Outcome Measures
Change in "Glasgow Hearing Aid Benefit Profile" at 8 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT03316287
First Posted
October 10, 2017
Last Updated
March 25, 2020
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT03316287
Brief Title
Big Data Supporting Public Health Hearing Policies
Acronym
EVOTION
Official Title
EVidenced Based Management of Hearing Impairments: Public Health pΟlicy Making Based on Fusing Big Data Analytics and simulaTION
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1080 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hearing aid + mobile phone
Arm Type
Experimental
Arm Title
Hearing aid + mobile phone + biosensor
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hearing aid
Intervention Description
Smart hearing aid to allow collection of real time hearing aid usage data
Intervention Type
Device
Intervention Name(s)
Mobile phone
Intervention Description
Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
Intervention Type
Device
Intervention Name(s)
Sensor
Intervention Description
Wearable biosensor for the collection of physiological data
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Guy's and St. Thomas' Foundation Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29449298
Citation
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.
Results Reference
derived
Learn more about this trial
Big Data Supporting Public Health Hearing Policies
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