Active not recruitingNAINTERVENTIONAL

Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

This study looks at how well remote care works for adults with a cochlear implant in their first year after it's switched on. We want to see if managing your implant care remotely, using special apps and tools, is as effective as going into a clinic for your appointments. We'll compare hearing performance between these two groups. The study also aims to figure out if remote care saves time and money for both patients and healthcare providers. By understanding the potential cost savings and efficiency gains, we can see if offering remote care for cochlear implants is a better, more convenient option for everyone involved.

At a glance

Status

Active not recruiting

Phase

Sponsor

Cochlear

Enrolment target

148

Start

18 Mar 2024

Estimated completion

01 Sep 2026

Hearing Loss

What is this study about?

This study is designed to compare two different ways of looking after adults who have recently received a cochlear implant. A cochlear implant is a small electronic device that helps people with severe hearing loss to hear. Once the implant is switched on, there's usually a period of adjustments and appointments to make sure it's working as well as it can for you. This study is focusing on that first year after your implant is activated (switched on).

We're comparing the usual way of doing things, where you visit the clinic for your appointments (we call this 'standard care'), with a newer approach called 'remote care'. Remote care uses special tools and apps that allow you to manage some aspects of your implant care from home, without needing to travel to the clinic every time. The main goal is to see if remote care helps people hear just as well as standard in-clinic care.

Beyond just hearing, the study also wants to understand the practical aspects of both types of care. We'll be looking at how much time is spent and what costs are involved for both patients and the healthcare system. This will help us determine if remote care could offer a more convenient and cost-effective way to manage cochlear implant aftercare for many people in the future.

Key takeaways

Compares remote vs. clinic care for cochlear implants.
Focuses on adults in their first year post-activation.
Aims to assess hearing outcomes and cost/time efficiency.
Requires a Cochlear™ implant and smartphone access.
You will be randomly assigned to either remote or standard care.
Could help make cochlear implant aftercare more convenient.

Who may be eligible?

To be considered for this study, you need to be an adult (18 or older) who has had a cochlear implant for about 3 months, but no longer than 12 months. Your hearing loss should be of a type where a cochlear implant is suitable, and you should be able to hear some words with your implant.

It's important that you have a Cochlear™ brand implant in one ear and are using a compatible sound processor. You'll also need to have a smartphone that can connect to the remote care tools and be comfortable using it. You should be happy to follow all the study instructions and allow yourself to be put into either the remote care or standard care group by chance.

There are also some reasons why you might not be able to join. For example, if your implant settings are very unusual or unstable, or if you need very detailed, frequent programming. People with other health conditions that would make it hard to take part in the evaluations, or those who work for Cochlear or are closely related to study staff, would also not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had your Cochlear™ implant switched on between 3 and 12 months ago?
Do you have a Cochlear™ brand implant in one ear and use a compatible sound processor?
Do you have a smartphone you can use for healthcare apps?
Are you able to speak the study's language fluently?
Are you willing to be randomly placed in either the remote or clinic care group?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to either the remote care group or the standard clinic care group – like flipping a coin. If you're in the remote care group, you'll use special apps and tools on your smartphone to manage some of your implant settings and check-ups from home. If you're in the standard care group, you'll continue to have your regular appointments at the clinic.

Over the course of the study, which will last up to 12 months, you'll have specific hearing tests and questionnaires to complete. These will help us understand how well you're hearing and how you're managing your implant. We'll also ask about the time you've spent on appointments or using remote tools. There are no new medications involved; it's all about how your existing cochlear implant care is delivered.

Potential risks and benefits

Taking part in this study may offer the benefit of potentially finding a more convenient way to manage your cochlear implant care through remote options. You'll also be contributing valuable information that could improve care for many other people with cochlear implants in the future. As with any study, there's always a small chance of unforeseen inconveniences related to appointments or technology use. However, your safety and well-being are paramount, and you are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ear Science Institute Australia
Verified postcode
Subiaco, Australia
UZ Gent
Verified postcode
Ghent, Belgium
UZ Leuven
Verified postcode
Leuven, Belgium
University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
Verified postcode
Bari, Italy
Azienda Ospedale Università di Padova
Verified postcode
Padova, Italy
Academisch Ziekenhuis Maastricht
Verified postcode
Maastricht, Netherlands
Radboud University Medical Centre Nijmegen
Verified postcode
Nijmegen, Netherlands
Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
Verified postcode
Birmingham, United Kingdom
Auditory Implant Centre, Glan Clwyd Hospital
Verified postcode
Bodelwyddan, United Kingdom
St Thomas' Hospital
Verified postcode
London, United Kingdom
St George's Hospital
Verified postcode
London, United Kingdom

Common questions

What is remote care for a cochlear implant?

Remote care means you can have some of your cochlear implant check-ups and adjustments done from home using special apps and tools on your smartphone, instead of always needing to visit the clinic.

Who is running this study?

This study is looking at how effective Cochlear's own remote care services are compared to standard in-clinic care for their implant users.

Will I still get good care if I'm in the remote group?

Yes, the study aims to ensure that remote care provides the same quality of hearing support as traditional clinic visits, maintaining your clinical care standards.

Do I have to pay to be in the study?

No, you do not have to pay to participate in the study. All study-related assessments and care will be provided as part of your participation.

What if I don't like using a smartphone for medical care?

If you're not comfortable with smartphones or meet certain other criteria, you might not be suitable for this particular study, especially if you were placed in the remote care group. Eligibility includes being able to use a compatible smartphone.