Active not recruitingNAINTERVENTIONAL

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)

The DREAM study is researching a new way to treat obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. It's investigating a device called the Genio™ system, which gently stimulates a nerve in the throat. This stimulation helps to keep the airway open, potentially leading to better sleep. The study wants to find out if this system is both safe to use and truly effective in helping adults who suffer from OSA. Participants will be carefully monitored to see how the device helps their breathing and sleep quality. This research is important for those who haven't found other treatments helpful or can't use them.

At a glance

Status

Active not recruiting

Phase

Sponsor

Nyxoah S.A.

Enrolment target

115

Start

14 Oct 2020

Estimated completion

01 Feb 2028

Obstructive Sleep Apnea

What is this study about?

This study, called DREAM, is looking into a new treatment for a common sleep problem called obstructive sleep apnea, or OSA. If you have OSA, the muscles in your throat relax too much while you sleep, causing your airway to narrow or even close. This can lead to snoring, gasping, and waking up frequently, making you feel tired and affecting your health.

The Genio™ system is a new type of device designed to help. It's an implantable device that gently stimulates the hypoglossal nerve in your throat. This nerve controls the muscles that keep your tongue and throat from collapsing, so stimulating it helps to keep your airway open while you sleep. The DREAM study aims to see how well this system works and if it's safe for people to use.

This research is important because it could offer a new option for people with OSA, especially those who haven't been able to use, or haven't found relief from, other common treatments like a CPAP machine. By participating, you could help doctors understand if this device is a suitable and effective option for many others living with sleep apnea, potentially improving their sleep and overall health.

Key takeaways

DREAM is testing a new device (Genio™ system) for sleep apnea.
It aims to see if the device is safe and helps keep airways open during sleep.
For adults aged 22-75 with moderate to severe sleep apnea who struggle with other treatments.
Participation involves surgery, regular check-ups, sleep tests, and long-term follow-up.
You can stop participating at any time.
Could offer a new treatment option if current methods aren't working for you.

Who may be eligible?

To join this study, you would generally need to be an adult between 22 and 75 years old. Your Body Mass Index (BMI), which is a measure of weight related to height, should be 32 or less. Also, you should have tried other sleep apnea treatments, like CPAP, and either couldn't tolerate them, they didn't work for you, or you decided not to use them.

Your sleep apnea needs to be of moderate to severe type, as confirmed by a sleep study. We'd also check a measurement around your neck called the cricomental space to make sure it's suitable for the device. You'll need to be willing to commit to all the study requirements, including follow-up appointments and sleep tests.

There are also reasons why you might not be able to join. For example, if you have other serious sleep disorders besides sleep apnea, or if you work night shifts regularly. Also, if you take certain medications that affect your breathing or sleep, or if there are certain physical features in your head or neck that would make the Genio™ system unsuitable.

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 between 22 and 75 years old?
Is your BMI (body weight to height ratio) 32 or less?
Have you tried other sleep apnea treatments (like CPAP) and they didn't work, or you couldn't use them?
Do you have moderate to severe obstructive sleep apnea?
Do you not work night shifts regularly (10 pm-7 am, 3+ nights a week)?
Are you able and willing to attend all study appointments and follow instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have some careful checks to make sure the Genio™ system is right for you. If you meet the criteria, you would have an operation to have the Genio™ system fitted. After the surgery, you'll have regular check-ups and sleep studies over time to see how well the device is working for you and how you're feeling. This includes filling out questionnaires about your sleep and overall health.

Before the surgery and during the follow-up period, you'll need to follow specific lifestyle guidance provided by the study team. You'll also need to attend all scheduled medical appointments and sleep tests for the entire duration of the study. This commitment extends to a long-term follow-up plan for up to five years after your surgery to see how you are doing over time.

Potential risks and benefits

Participating in this study could potentially offer you a new way to manage your obstructive sleep apnea, which might improve your sleep quality and overall health if the Genio™ system works for you. Like any medical procedure involving a device and surgery, there are potential risks, such as those associated with any operation or with the device itself. The study team will explain all known risks to you in detail. Remember, joining a clinical study is completely voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (21)

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
ENT and Allegy Associates South Florida
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Boca Raton, United States
University of South Florida-Tampa General Medical Center
Verified postcode
Tampa, United States
Advanced Ear Nose & Throat Associates
Verified postcode
Atlanta, United States
CENTA (Center for ENT & Allergy)
Verified postcode
Carmel, United States
University of Iowa- Institute for Clinical & Translational Science
Verified postcode
Iowa City, United States
Harvard/ Massachusetts Eye & Ear
Verified postcode
Boston, United States
Weill Cornell Medicine Otolaryngology - Head and Neck Surgery
Verified postcode
New York, United States
The Ohio State University, Wexner Medical Center
Verified postcode
Columbus, United States
Ohio Sleep Medicine Institute
Verified postcode
Dublin, United States
Thomas Jefferson University Department of Otolaryngology
Verified postcode
Philadelphia, United States
University of Pennsylvania
Verified postcode
Philadelphia, United States

Common questions

What is Obstructive Sleep Apnea (OSA)?

OSA is when your breathing repeatedly stops and starts during sleep because your airway narrows or closes, leading to interrupted sleep and daytime tiredness.

What is the Genio™ system?

It's a new device that gently stimulates a nerve in your throat to help keep your airway open while you sleep, aiming to treat OSA.

Who is this study for?

It's for adults aged 22-75 with moderate to severe OSA who haven't found other treatments, like CPAP, suitable or effective.

How long will I be in the study?

You'll be followed closely after surgery, and then for up to five years, with regular check-ups and assessments.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point, and it won't affect your future medical care.