Mobile telephone audio compensation service for hearing impaired users.

ISRCTN ISRCTN13832950
DOI https://doi.org/10.1186/ISRCTN13832950
Secondary identifying numbers Goshawk Clinical Protocol 2
Submission date
28/03/2018
Registration date
13/04/2018
Last edited
24/01/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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.

Contact information

Mr Jeff McBride
Public

c/o Goshawk
Compass House
Cooil Road
Douglas
IM2 2QZ
Isle of Man

Phone 07770904371
Email jeff@mcbridecq.com

Study information

Study designSingle-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 designInterventional
Secondary study designNon randomised study
Study setting(s)Community
Study typeQuality of life
Participant information sheet No participant information sheet available
Scientific titleMobile telephony audio compensation service for use by individuals with sensorineural hearing impairment.
Study acronymGoshawk Audio Compensation Service
Study objectivesUse of a mobile telephone is enhanced for users with impaired hearing through the Goshawk device.
Ethics approval(s)Isle of Man Regional Ethics Committee, approval pending
Health condition(s) or problem(s) studiedHearing impairment
InterventionUpon 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureUser 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 measuresImproved user experience of mobile telephone as measured by call time/frequency increase.
Overall study start date31/01/2018
Completion date31/08/2018

Eligibility

Participant type(s)All
Age groupAdult
SexBoth
Target number of participants50-100
Total final enrolment53
Key inclusion criteriaIndividuals with known or suspected hearing impairment
Key exclusion criteriaChronic deafness
Date of first enrolment28/03/2018
Date of final enrolment31/05/2018

Locations

Countries of recruitment

  • Isle of Man

Study participating centre

Goshawk Offices
Compass House
Cooil Road
Douglas
IM22QZ
Isle of Man

Sponsor information

Goshawk
Industry

Compass House
Cooil Road
Douglas
IM2 2QZ
Isle of Man

Phone 07807 323 021
Email matthew@goshawk-communications.com
Website http://goshawk-communications.com

Funders

Funder type

Not defined

Goshawk

No information available

Results and Publications

Intention to publish date31/07/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2019 24/01/2020 Yes No

Editorial Notes

24/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.