Hearing LossEVOTIONNCT03316287
Big Data Supporting Public Health Hearing Policies
A study testing Hearing aid, Mobile phone and Sensor in people with Hearing Loss, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing aid, Mobile phone and Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVidenced Based Management of Hearing Impairments: Public Health pΟlicy Making Based on Fusing Big Data Analytics and simulaTION
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.
Read more
This will be done by:
- 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.
- Conditions
- Hearing Loss
- Being tested
- Hearing aid, Mobile phone, Sensor
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aidDevice
Smart hearing aid to allow collection of real time hearing aid usage data
Mobile phoneDevice
Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
SensorDevice
Wearable biosensor for the collection of physiological data
| Study group | Role | What they receive |
|---|---|---|
| Hearing aid + mobile phone | Experimental | Not described Receives: Device: Hearing aid; Device: Mobile phone |
| Hearing aid + mobile phone + biosensor | Experimental | Not described Receives: Device: Hearing aid; Device: Mobile phone; Device: Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in "Glasgow Hearing Aid Benefit Profile" at 8 weeks
Measured: Baseline (i.e. before the patient receives a hearing-aid) and at 8 weeks after receiving a hearing-aid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Mar 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316287
- Sponsor's protocol ID
- 17/0064
- Acronym
- EVOTION
- Status last verified
- Mar 2020
- First submitted
- 10 Oct 2017
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29449298
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVidenced Based Management of Hearing Impairments: Public Health pΟlicy Making Based on Fusing Big Data Analytics and simulaTION
- ClinicalTrials.gov ID
- NCT03316287
- Acronym / sponsor ID
- EVOTION / 17/0064
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing aid + mobile phone | Experimental | Device: Hearing aid, Device: Mobile phone |
| Hearing aid + mobile phone + biosensor | Experimental | Device: Hearing aid, Device: Mobile phone, Device: Sensor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aidSmart hearing aid to allow collection of real time hearing aid usage data | Device | Hearing aid + mobile phone, Hearing aid + mobile phone + biosensor |
| Mobile phoneMobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests | Device | Hearing aid + mobile phone, Hearing aid + mobile phone + biosensor |
| SensorWearable biosensor for the collection of physiological data | Device | Hearing aid + mobile phone + biosensor |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 29449298Dritsakis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aid, Mobile phone and Sensor in people with Hearing Loss, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03316287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.