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EURO-STIM Registry

The EURO-STIM Registry is gathering information about the Inspire System for people who have Obstructive Sleep Apnoea (OSA). This system is a treatment designed to help with breathing during sleep. The study aims to see how well the Inspire System works over a long period and how often people use it as advised. Researchers collect this information during your routine check-ups, so there are no extra tests or treatments required beyond your usual care. It helps us understand the real-life experience of using the Inspire System to improve sleep and health.

At a glance

Status
Recruiting
Sponsor
Inspire Medical Systems, Inc.
Enrolment target
1,000
Start
26 May 2025
Estimated completion
01 Apr 2035

What is this study about?

This study, called the EURO-STIM Registry, is designed to learn more about a treatment for Obstructive Sleep Apnoea (OSA) called the Inspire System. OSA is a common condition where your breathing repeatedly stops and starts while you sleep. The Inspire System is a small device implanted under the skin that helps to keep your airway open during sleep.

This registry isn't testing a new treatment or asking you to do anything extra. Instead, it observes how people who already have or are about to receive an Inspire implant get on with it over time. The main goal is to understand how effective the Inspire System is as a long-term treatment in real-world situations, how easy it is for people to use consistently, and what their experiences are like.

By collecting this information during your regular clinic visits, researchers can build a complete picture of the Inspire System's journey from when it's first used, through all the years someone has it. This helps doctors and patients understand the full benefits and any challenges of this treatment, ultimately helping more people manage their OSA better.

Key takeaways

  • It's about understanding the Inspire System for sleep apnoea.
  • Data collected during your usual clinic visits.
  • No extra appointments or treatments needed.
  • Helps improve future care for people with OSA.
  • You must already have or be getting an Inspire implant.
  • Your medical care is not affected by participating.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) who has received an Inspire implant or is about to get one. You must be able to understand the study and agree to take part. It's also important that you are willing to attend your regular clinic appointments, as this is where the study will gather its information.

However, some people won't be able to join. If a doctor believes you have a serious illness that means you might not live for at least another year, you won't be eligible. Also, if your doctor thinks there's any other reason why it wouldn't be safe or appropriate for you to participate, then you would not be included.

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.

  1. Are you 18 years old or older?
  2. Do you currently have an Inspire implant or are you going to get one?
  3. Can you understand and agree to take part in the study?
  4. Are you willing to attend your regular appointments for your Inspire treatment?
  5. Does your doctor believe you have a life expectancy of more than a year?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this registry, it will be very simple for you. You won't have any extra appointments, tests, or treatments. All the information for the study will be collected during your normal, routine clinic visits for your Inspire therapy management. This means you will just continue with your usual healthcare plan, and your information will be recorded as part of the study. There's no specific 'total duration' for your involvement; information will be gathered for as long as you are attending your regular follow-up appointments.

Potential risks and benefits

Taking part in this registry comes with no additional medical risks, as you won't be undergoing any new treatments or procedures. The main benefit is that your experience will help doctors and researchers understand how well the Inspire System works in the long run for people like you. This information can improve care for future patients with Obstructive Sleep Apnoea. You are free to withdraw from the registry at any time without it affecting your medical care.

Locations (21)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Klinikum Klagenfurt, KABEG
    Verified postcode
    Klagenfurt, Austria· Not yet recruiting
  • Ordensklinikum Linz
    Verified postcode
    Linz, Austria· Not yet recruiting
  • Universitair Ziekenhuis Antwerpen
    Verified postcode
    Edegem, Belgium· Not yet recruiting
  • Angers University Hospital Center
    Verified postcode
    Angers, France· Not yet recruiting
  • CHU Grenoble Alpes
    Verified postcode
    La Tronche, France· Not yet recruiting
  • Clinique de la Louviere
    Verified postcode
    Lille, France· Not yet recruiting
  • Hôpital d'Instruction des Armées Laveran
    Verified postcode
    Marseille, France· Not yet recruiting
  • Clinique Beausoleil
    Verified postcode
    Montpellier, France· Not yet recruiting
  • CHU Saint Etienne
    Verified postcode
    Saint-Priest-en-Jarez, France· Not yet recruiting
  • Asklepios Klinik Hamburg
    Verified postcode
    Hamburg, Germany· Recruiting
  • Universitatsklinikum Hamburg Eppendorf
    Verified postcode
    Hamburg, Germany· Recruiting
  • Klinik für HNO-Heilkunde/HNO-Schlaflabor
    Verified postcode
    Lübeck, Germany· Not yet recruiting

Common questions

What is the Inspire System?

The Inspire System is a device implanted in your body that helps prevent your airway from closing during sleep, treating Obstructive Sleep Apnoea.

Do I need extra appointments for this study?

No, all information for the study is collected during your normal, routine clinic visits for your Inspire therapy.

Will taking part change my medical treatment?

No, your medical care and treatment plan for your Inspire System will remain exactly the same.

Can I stop participating in the study if I change my mind?

Yes, you can withdraw from the study at any time, and it will not affect your medical care.

What is Obstructive Sleep Apnoea (OSA)?

OSA is a condition where your breathing repeatedly stops and starts while you are asleep, due to your airway becoming blocked.

How to find out more

Elyse Ebeling

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "EURO-STIM Registry…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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