Active not recruitingNAINTERVENTIONAL

A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults

This study is checking a device called the Genio® system for adults who have a snoring and breathing problem called obstructive sleep apnea (OSA). We want to see over five years if this system is safe and truly helps people with moderate to severe OSA. This is important for those who haven't found other common treatments like breathing machines (CPAP) or mouth guards helpful, or can't use them. The study will follow patients after they have the Genio® system put in, checking their progress at different times for up to five years after their surgery. It's an important step to understand how well this new treatment supports people in the long term.

At a glance

Status

Active not recruiting

Phase

Sponsor

Nyxoah S.A.

Enrolment target

110

Start

01 Sep 2019

Estimated completion

01 Oct 2030

Obstructive Sleep Apnea

What is this study about?

This study is about a medical device called the Genio® system, which is designed to help adults who have a sleep problem called obstructive sleep apnea (OSA). OSA happens when your throat muscles relax too much during sleep, causing your airway to narrow or close, which stops your breathing for short periods. This can lead to loud snoring, feeling tired during the day, and other health issues.

The main goal of this study is to see if the Genio® system is safe and if it truly helps people with moderate to severe OSA breathe better and sleep more soundly. Researchers will be following patients for five years after they have the device fitted to gather this important information. This type of study, called a Post-market Clinical Follow-up, helps us understand how a new treatment performs in real-world conditions over a longer period after it's already available.

This research is particularly important for people who haven't been able to use or benefit from other common treatments for sleep apnea, like Continuous Positive Airway Pressure (CPAP) machines or special mouthguards (mandibular advancement devices). By participating, you would be helping medical science learn more about how to effectively treat OSA for a wider range of patients.

Key takeaways

This study is for adults with moderate to severe obstructive sleep apnea (OSA).
It's looking at the Genio® system as a long-term treatment option.
The study follows patients for 5 years after surgery.
It's for people who haven't had success with other OSA treatments.
The main goals are to check the device's safety and how well it works.
Participation involves surgery and regular follow-up visits and phone calls.

Who may be eligible?

To join this study, adults must be 18 years or older. You should have moderate to severe obstructive sleep apnea (OSA), confirmed by a sleep study, where your breathing stopping and starting happens between 15 and 65 times per hour. You also need to have tried other common treatments for OSA, like a CPAP machine or a mouthguard, and found they didn't work for you, you couldn't tolerate them, or you chose not to use them. Your body mass index (BMI) – a measure of weight to height – should also be below 35.

There are some reasons why you might not be able to join. For example, if you have other untreated sleep problems that aren't OSA, or if you're taking medicines that might affect your consciousness or breathing during sleep. Major physical issues in your throat or mouth that could stop the Genio® system from working properly, or untreated mental health conditions that might make it hard to follow the study's requirements, would also mean you couldn't take part.

Additionally, if you have a life expectancy of less than 12 months, or are already involved in another clinical study right now (unless it's just a registry), you wouldn't be able to participate in this one.

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?
Do you have moderate to severe obstructive sleep apnea (OSA)?
Have other OSA treatments (like CPAP or a mouthguard) not worked for you?
Is your Body Mass Index (BMI) below 35?
Do you have any other untreated serious sleep, mental health, or breathing problems?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have the Genio® system fitted through a surgical procedure. After your surgery, the device will be switched on between 6 to 10 weeks later. You will then have several follow-up appointments at the clinic: at 3 months, 6 months, 9 months, and 12 months after the device is activated. After the first year, you will have yearly check-ups at the clinic for a total of 5 years following your surgery.

In between some of the clinic visits, specifically at 18 months, 30 months, 42 months, and 54 months, a member of the study team will contact you by phone to check in on your progress and well-being. Throughout these five years, the study team will be carefully monitoring the safety and how well the Genio® system is working for you. There is no mention of specific medications given as part of this study, but your usual medications will be reviewed.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of joining this study is that the Genio® system might help improve your obstructive sleep apnea, potentially leading to better sleep and overall health, especially if other treatments haven't worked for you. However, as with any surgery, there are risks involved, including the risks associated with the operation itself and the possibility of side effects from the device. The study is designed to carefully monitor for any safety concerns and how well the device works. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (19)

Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
Verified postcode
Antwerp, Belgium
Universitair Ziekenhuis Antwerpen
Verified postcode
Antwerp, Belgium
CHU - Angers
Verified postcode
Angers, France
Hôpital Henri-Mondor AP-HP
Verified postcode
Créteil, France
Hôpital Privé La Louvière
Verified postcode
Lille, France
Clinique Beau-Soleil
Verified postcode
Montpellier, France
Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
Verified postcode
Paris, France
CEREVES Paris Jean Jaurès - Centre du sommeil
Verified postcode
Paris, France
Hôpital Tenon AP-HP
Verified postcode
Paris, France
Clinique Mutualiste de la Sagesse
Verified postcode
Rennes, France
Polyclinique Saint Laurent
Verified postcode
Rennes, France
CHU Toulouse
Verified postcode
Toulouse, France

Common questions

What is obstructive sleep apnea (OSA)?

OSA is a common condition where your breathing repeatedly stops and starts while you sleep because your throat muscles relax too much and block your airway.

What is the Genio® system?

The Genio® system is a medical device designed to help adults with OSA. This study is looking at how safe and effective it is over the long term.

How long will I be in the study?

If you join, you will be followed for a full 5 years after your surgery to have the Genio® system fitted.

What if I've tried other sleep apnea treatments?

This study is specifically for people who couldn't use, didn't tolerate, or found that other treatments like CPAP machines or mouthguards didn't work for them.

Can I leave the study if I change my mind?

Yes, you are free to stop participating in the study at any time, for any reason, without it affecting your medical care.