124 Participants Needed

Genio Bilateral Stimulation for Obstructive Sleep Apnea

(ACCCESS Trial)

Recruiting at 14 trial locations
JB
DM
DU
CP
JS
JS
BM
Overseen ByBrendan McBrine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests a new device called the Genio® 2.1 System for people with moderate to severe sleep apnea. The device sends small electrical pulses to a nerve in the tongue, making it contract and keeping the airway open during sleep. The Genio® 2.1 System is part of a line of treatments involving electrical stimulation of the hypoglossal nerve to manage obstructive sleep apnea by maintaining airway patency.

Do I need to stop my current medications to join the trial?

The trial excludes participants taking medications that may alter consciousness, respiration, or sleep patterns. You might need to stop such medications, but the protocol doesn't specify a washout period. It's best to discuss your specific medications with the trial investigator.

What data supports the idea that Genio Bilateral Stimulation for Obstructive Sleep Apnea is an effective treatment?

The available research shows that Genio Bilateral Stimulation is effective for treating obstructive sleep apnea. One study describes a successful case where a patient with moderate obstructive sleep apnea was treated with the Genio system. Another study highlights that this treatment reduces the severity of sleep apnea by activating muscles that keep the airway open, showing effectiveness six months after the device is implanted. Additionally, the treatment is considered safe and satisfactory for patients, especially those who cannot use other common treatments like CPAP. Overall, the data supports that Genio Bilateral Stimulation is a promising option for managing obstructive sleep apnea.12345

What safety data is available for the Genio bilateral stimulation treatment for obstructive sleep apnea?

The Genio bilateral hypoglossal nerve stimulation system has been evaluated in several studies. It is described as a novel device for treating obstructive sleep apnea (OSA) by activating the genioglossus muscle to decrease upper airway collapsibility. Safety and effectiveness were assessed at 6 months post-implantation, showing promising results. The system has been made available for regular patient care in Germany since 2021, with publications indicating its safety, efficacy, and patient satisfaction. A multicenter German study reported significant improvements in sleep and daytime symptoms, with no surgical revisions required, indicating the treatment is safe and effective.12356

Is the Genio System a promising treatment for obstructive sleep apnea?

Yes, the Genio System is a promising treatment for obstructive sleep apnea. It works by stimulating the hypoglossal nerve, which helps keep the airway open during sleep. Studies have shown that it can effectively reduce the severity of sleep apnea and improve the quality of life for patients who use it.12378

Research Team

JS

Jey Subarroyan, PhD

Principal Investigator

Nyxoah S.A.

Eligibility Criteria

This trial is for adults aged 22-75 with moderate to severe obstructive sleep apnea who haven't had success with or can't tolerate standard treatments like CPAP. Participants should have a BMI ≤ 32 kg/m2, be able to follow the study's requirements, and not be planning pregnancy. Exclusions include prior surgeries affecting the airway, life-threatening diseases, psychiatric conditions that affect compliance, other significant sleep disorders, and substance abuse within the last three years.

Inclusion Criteria

I have moderate to severe sleep apnea confirmed by tests.
My sleep study showed complete blockage at the soft palate level.
Your body mass index (BMI) must be 32 or lower.
See 4 more

Exclusion Criteria

I do not have a psychiatric condition that stops me from following study procedures.
I do not have major airway or swallowing issues that would affect the Genio® System's effectiveness.
You have serious health conditions that make surgery or anesthesia risky, such as severe heart problems, uncontrolled high blood pressure, or certain neurological disorders.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Genio® 2.1 System implant and undergo hypoglossal nerve stimulation

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Participants continue to be monitored for long-term safety and effectiveness

3 years

Treatment Details

Interventions

  • Genio System
Trial Overview The Genio System is being tested for its safety and effectiveness in treating patients with complete concentric collapse (CCC) of the upper airway during sleep. The system uses bilateral hypoglossal nerve stimulation (HGNS) as an alternative treatment method for those who struggle with traditional therapies.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Genio® 2.1 SystemExperimental Treatment1 Intervention
System Component Genio® System 2.1 Implantable Stimulator (IS) Genio® Implantable Stimulator External Stimulator (ES) Genio® External Stimulator Disposable Patch (DP) Genio® Disposable Patch Activation Chip (AC) Genio® Activation Chip (AC) Model #2364 Charging Unit (CU) Genio® Charging Unit (CU) Model #2238 Sleep Lab Application Genio® Sleep Lab Application Smartphone Application (optional) Genio® Smartphone Application

Genio System is already approved in European Union, Switzerland for the following indications:

🇪🇺
Approved in European Union as Genio for:
  • Obstructive Sleep Apnea (OSA)
  • Complete Concentric Collapse (CCC)
🇨🇭
Approved in Switzerland as Genio for:
  • Obstructive Sleep Apnea (OSA)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nyxoah S.A.

Lead Sponsor

Trials
7
Recruited
460+

Nyxoah Inc.

Industry Sponsor

Trials
2
Recruited
240+

Findings from Research

The bilateral hypoglossal nerve stimulator (Genio system) was successfully implanted in a 60-year-old woman with moderate obstructive sleep apnea, showing no complications during surgery and recovery.
After 6 months, the device significantly reduced apnea and hypopnea events by 88% and improved oxygen saturation levels from 78% to 91%, indicating its efficacy in treating obstructive sleep apnea.
Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea.Lewis, R., Pételle, B., Campbell, MC., et al.[2022]
The Genio™ system for bilateral hypoglossal nerve stimulation (HNS) significantly reduced the severity of obstructive sleep apnea (OSA) after 6 months, with the apnoea-hypopnoea index (AHI) decreasing from 23.7 to 12.9 events per hour (p<0.001).
Participants also reported improvements in daytime sleepiness and sleep-related quality of life, with no serious device-related adverse events occurring during the study, indicating a safe and effective treatment option.
Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.Eastwood, PR., Barnes, M., MacKay, SG., et al.[2021]
Hypoglossal nerve stimulation (HNS) is an effective treatment for obstructive sleep apnea (OSA) by increasing the muscle tone of the genioglossus muscle, which helps keep the airway open.
Breathing synchronized HNS has shown strong safety and efficacy results, while newer continuous and bilateral HNS methods are emerging with promising but limited data, indicating a need for further research in these areas.
[Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea].Maurer, JT., Troia, R., Leitzbach, S.[2021]

References

Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea. [2022]
Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. [2021]
[Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea]. [2021]
Preoperative Predictors of Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. [2020]
Optimization of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea With Ultrasound Assessment of Tongue Movement. [2022]
Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. [2022]
Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. [2022]
[Upper Airway Stimulation in OSA]. [2018]