Plain English Summary
Background and study aims
A cochlear implant is a surgically implanted electronic device that provides a sensation of hearing to adults and children with severe to profound deafness. About 1,200 people receive a cochlear implant in the UK each year. At the moment people with implants need to come back to their cochlear implant centre every year for checks. There are only around 20 cochlear implant centres in the UK, so people can live several hours away. Coming to the cochlear implant centre can be expensive for some people, and can mean time off work for people using implants and their families. We would like to have some tools that people using implants could have at home so they could send the results to the clinician to see if they need to come to the centre or not. It could also help clinicians decide how long an appointment should be. We have developed a new set of tests that could be used to work out if someone using a cochlear implant needs to come to the cochlear implant centre. The tests are very similar to those done in the clinic: a hearing test, a speech understanding test using numbers, checking the internal implant, downloading the current settings, and some questionnaires. Some will be done on an iPad and some using the usual software the audiologists use. We want to know how people using implants feel about these tests. We will also ask clinicians if there is anything else they need in order to decide if someone needs to the cochlear implant centre or not.
Who can participate?
Adults or children (aged 4 and over) who have used a cochlear implant (a CP900 series sound processor and a CI500, CI24RE, Nucleus 24 Series or CI422 internal implant) for at least 3 months, and who have a routine clinical appointment scheduled during the study period.
What does the study involve?
The study involves the participants undergoing the new tests before their appointment with the audiologist. The audiologist then looks at the results to see if they give enough information to decide what the patient needs help with. They then attend the usual appointment with the audiologist. All study testing takes place in the hour before the appointment. The new tests are:
1. Digit Triplet Test: a hearing test listening to numbers and repeating them
2. Aided thresholds: listening and responding to quiet beeps, like in the clinic
3. Telemetry: checking of the internal implant, like the audiologist does in clinic, including downloading settings from the speech processor, for example how the patient has worn the processor. The audiologist always does this in clinic too
4. Filling in a questionnaire about how the patient/carer is feeling about their hearing, how much the processor is being used, and if there is anything the patient needs help with
5. The tester takes a photo of the implant site behind the ear
The audiologist then looks at these results and fills in a questionnaire about whether the results are enough to decide what sort of appointment (if any) is needed.
What are the possible benefits and risks of participating?
There will not be any direct benefits to the participant. However, it may enable us to improve our service for people with cochlear implants in the future. New speech testing software will be used to deliver the sounds for the tests. As with any software, there is a small risk of hearing sounds that are uncomfortably loud. If this happens, the participant can stop the sound immediately by taking off the speech processor coil/headpiece. The participant can stop the project at any point, without having to say why.
Where is the study run from?
The project is led by University of Southampton Auditory Implant Service. The other centres are: The Emmeline Centre for Hearing Implants, Cambridge; Scottish Cochlear Implant Programme, Kilmarnock; Nottingham Auditory Implant Programme, Nottingham.
When is the study starting and how long is it expected to run for?
May 2016 to May 2017
Who is funding the study?
Cochlear Ltd (Australia)
Who is the main contact?
Dr Helen Cullington
Trial website
Contact information
Type
Public
Primary contact
Dr Helen Cullington
ORCID ID
http://orcid.org/0000-0002-5093-2020
Contact details
University of Southampton Auditory Implant Service
Highfield
Southampton
SO17 1BJ
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CLTD-5654
Study information
Scientific title
Evaluation of test battery for remote monitoring of cochlear implants
Acronym
Study hypothesis
Primary: With the test battery the clinician is able to detect all issues that might need intervention.
Secondary: The number of recipients or parents/carers who find remote monitoring an acceptable method to determine the need for a clinical visit will be greater than the number who do not.
Ethics approval
1. East of England - Cambridgeshire and Hertfordshire Research Ethics Committee, 31/05/2016, ref: 16/EE/0177
2. Health Research Authority, 03/11/2016, ref: 16/EE/0177
Study design
Unblinded prospective multicentre investigation using repeated-measures single-subject design conducted in one session only
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Other
Patient information sheet
See additional files
Condition
Severe to profound deafness
Intervention
The following procedures that are part of the remote monitoring test battery will be conducted with the patient using a cochlear implant just before they see the clinician or their standard appointment:
1. Digit Triplet Test
2. Aided thresholds using iPad
3. Picture of scalp over implant site
4. Implant telemetry measurements
5. Completion of a questionnaire (by parent/carer in case of paediatric recipients) that includes questions regarding any sound quality issues they are experiencing and any other issues that might require clinical intervention.
6. Collection of processor usage and environment information using datalogs or by questionnaire.
The clinician will be asked to review the above mentioned data collected and will report if the data is sufficient to determine the need for intervention, and what type of intervention is required. This information will be captured in a questionnaire.
The patient will then have the standard clinical session. All tasks completed in the clinical session will be recorded in a clinician questionnaire. The clinician will report any interventions conducted in the clinical session that were in addition to those determined during the review of test battery data. The sources of information that helped the clinician to determine the need for the additional interventions will also be recorded in the questionnaire.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Whether the test battery provides sufficient information for the clinician to determine if the recipient needs any intervention, assessed through the Clinician Questionnaire at the single study visit
Secondary outcome measures
Secondary endpoint
The acceptance of the concept of remote monitoring for recipients or parent/carers, assessed through the Recipient/Parent Questionnaire at the single study visit
Exploratory endpoint
Feedback from clinicians regarding any additional clinical metrics that will increase the acceptability of the test battery for remote monitoring captured; collected at the single study visit
Overall trial start date
31/05/2016
Overall trial end date
28/02/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults (>18 years) using cochlear implants or children (>4 years) using cochlear implants
2. Implanted with the CI500 series, CI24RE, Nucleus 24 Series or CI422 cochlear implants
3. User of commercially available CP900 series sound processor
4. At least 3 months experience with the cochlear implant
5. Ability to complete closed set speech perception of numbers 0 to 9 in the language used for the Digit Triplet Test (English)
6. Willingness to participate in and to comply with all requirements of the protocol
7. Routine clinical appointment scheduled during the study period
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Adults or parents/carers with limited English that would prevent completion of questionnaires
2. Nucleus 22 cochlear implant recipients
3. Additional handicaps that would prevent participation in evaluations
4. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures
Recruitment start date
31/05/2016
Recruitment end date
28/02/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton Auditory Implant Service
Highfield
Southampton
SO17 1BJ
United Kingdom
Trial participating centre
The Emmeline Centre for Hearing Implants
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
Scottish Cochlear Implant Programme
Kilmarnock
KA2 0BE
United Kingdom
Trial participating centre
Nottingham Auditory Implant Programme
Nottingham
NG1 5DU
United Kingdom
Funders
Funder type
Industry
Funder name
Cochlear
Alternative name(s)
Cochlear Ltd.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Australia
Results and Publications
Publication and dissemination plan
The results of the study will be published at the conclusion of the study.
At this stage the data storage format does not support sharing of the anonymised data to external parties. The decision of whether to allow access or not will be made only after the study report is written.
Intention to publish date
28/02/2018
Participant level data
To be made available at a later date
Basic results (scientific)
See additional files
Publication list
Publication citations
Additional files
- ISRCTN13600782_PIS_14Sep2016_adult.pdf Uploaded 28/09/2016
- ISRCTN13600782_PIS_14Sep2016_child.pdf Uploaded 28/09/2016
- ISRCTN13600782_PIS_14Sep2016_parent.pdf Uploaded 28/09/2016
- ISRCTN13600782_PIS_14Sep2016_young child.pdf Uploaded 28/09/2016
- ISRCTN13600782_BasicResults_20Nov2020.pdf uploaded 20/11/2020