Condition category
Ear, Nose and Throat
Date applied
28/03/2018
Date assigned
13/04/2018
Last edited
11/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://goshawk-communications.com

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

Publication citations

Additional files

Editorial Notes