Plain English Summary
Background and study aims
Current mobile telephone technology reduces the range of sounds transmitted, which is considered to be acceptable to users with normal hearing. However, it's a known issue that hearing impaired individuals can be negatively affected by this. Goshawk is developing a medical device which Goshawk believes can improve the user experience. Previous trials in a laboratory setting showed 70% of users expressed a preference for the Goshawk-processed audio compared to standard mobile phone calls. This study aims to show that using the device in a commercial mobile phone network improves the user experience of mobile telephone calls.
Who can participate?
Men or women with a known or suspected hearing impairment.
What does the study involve?
Participants are given access to the Goshawk service, which consists of a web-based hearing assessment tool and a real-time audio compensation service applied to the user's mobile telephone (via the Goshawk SIM). The sound enhancement is based on the user's hearing test results, from the web-based hearing assessment tool.
What are the possible benefits and risks of participating?
The possible benefits are improved audio quality on mobile telephone calls, resulting in an improved user experience. There are no known side effects to the use of this service, in conjunction with the standard mobile telephones available on the market.
Where is the study run from?
The study will be run from the Goshawk offices in Compass House, Isle of Man.
When is the study starting and how long is it expected to run for?
Recruitment for the study has provisionally started. The intervention part of the study is due to commence on 1st May 2018 and is expected to run for 4 to 8 weeks. Recruitment will continue until the target number of users is between 50 and 100.
Who is funding the study?
The study is being funded by a combination of Goshawk, Isle of Man Government Department of Health and Social Care and Manx Telecom.
Who is the main contact?
The main contact for the purposes of the trial registration is the contact in the registration record, Jeff McBride, the Goshawk Quality Representative. E-mail jeff@mcbridecq.com.
Trial website
Contact information
Type
Public
Primary contact
Mr Jeff McBride
ORCID ID
Contact details
c/o Goshawk
Compass House
Cooil Road
Douglas
IM2 2QZ
Isle of Man
07770904371
jeff@mcbridecq.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Goshawk Clinical Protocol 2
Study information
Scientific title
Mobile telephony audio compensation service for use by individuals with sensorineural hearing impairment.
Acronym
Goshawk Audio Compensation Service
Study hypothesis
Use of a mobile telephone is enhanced for users with impaired hearing through the Goshawk device.
Ethics approval
Isle of Man Regional Ethics Committee, approval pending
Study design
Single-centre case-controlled study
Interventional study over 4 to 8 weeks, single centre case control study on individuals known or suspected to have hearing impairment to provide evidence that the Goshawk device enhances the users experience of using a mobile telephone
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Community
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Hearing impairment
Intervention
Upon commencement of the trial, users will be granted access to the Goshawk product, which delivers real-time audio enhancement over communications networks (initially to mobile telephones, but also applicable to fixed telephony or VoIP applications). Thereafter, any and all calls made using the Goshawk service (via an enabled SIM in their mobile telephone) will be subject to intervention, until the end of the trial (either by normal expiry, or by a user request to leave the trial). The device enhances the user experience of mobile telephone calls
Intervention type
Device
Phase
Drug names
Primary outcome measure
User experience measured by an online questionnaire and audibility testing at baseline, at start of service activation, after 4 weeks of use and after deactivation of the service. The audibility test will be conducted by a trial administrator who will conduct verbal testing over the telephone (with the service active), utilising 'Harvard Sentences' (as developed by the IEE, a series of phonetically balanced sentences). The user will be asked to repeat the sentence to the administrator. The first three timepoints will involve testing using 3 of 10 sentences. The last timepoint will use all 10 sentences.
Secondary outcome measures
Improved user experience of mobile telephone as measured by call time/frequency increase.
Overall trial start date
31/01/2018
Overall trial end date
31/08/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Individuals with known or suspected hearing impairment
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
50-100
Participant exclusion criteria
Chronic deafness
Recruitment start date
28/03/2018
Recruitment end date
31/05/2018
Locations
Countries of recruitment
Isle of Man
Trial participating centre
Goshawk Offices
Compass House
Cooil Road
Douglas
IM22QZ
Isle of Man
Sponsor information
Organisation
Goshawk
Sponsor details
Compass House
Cooil Road
Douglas
IM2 2QZ
Isle of Man
07807 323 021
matthew@goshawk-communications.com
Sponsor type
Industry
Website
Funders
Funder type
Not defined
Funder name
Goshawk
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository access to which can be requested by any interested party.
Intention to publish date
31/07/2019
Participant level data
Stored in repository
Basic results (scientific)
Publication list