Genio Bilateral Stimulation for Obstructive Sleep Apnea

(ACCCESS Trial)

Not currently recruiting at 15 trial locations

Overseen By Dave Juco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nyxoah S.A.

Must not be taking: Consciousness-altering, Anticoagulants

Disqualifiers: Severe insomnia, Hypertension, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Genio System, designed to assist people with obstructive sleep apnea (OSA) who haven't found success with treatments like CPAP machines. The device uses gentle stimulation to keep airways open during sleep. It suits individuals with moderate to severe OSA who experience complete airway collapse at the back of the throat and find other treatments uncomfortable or ineffective. Participants must be comfortable with the study's requirements, such as attending follow-up visits and undergoing sleep studies. As an unphased trial, this study provides an opportunity to explore a novel treatment option for those seeking alternatives to traditional therapies.

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 prior data suggests that the Genio System is safe for treating obstructive sleep apnea?

Research has shown that the Genio System is generally safe for people with obstructive sleep apnea. One study found that stimulating a nerve in the tongue with this system was safe, and most participants tolerated the treatment well. Significant improvements in sleep apnea symptoms occurred without serious side effects.

The FDA has also approved the Genio System for treating moderate to severe obstructive sleep apnea. This approval indicates that it has passed safety checks, enhancing confidence in its safety for this trial.

Overall, evidence suggests that the Genio System is well-tolerated and safe based on previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for obstructive sleep apnea, which often involve continuous positive airway pressure (CPAP) machines or oral appliances, the Genio System offers a novel approach using bilateral neurostimulation. This system is unique because it involves an implantable stimulator that works by stimulating the hypoglossal nerve to keep the airway open during sleep. Researchers are excited about the Genio System because it provides a less invasive and potentially more comfortable alternative for patients who struggle with CPAP machines, offering a promising new avenue for improving sleep quality and overall health.

What evidence suggests that the Genio System is effective for obstructive sleep apnea?

Studies have shown that the Genio System, which stimulates a nerve that helps control the tongue, can reduce the severity of obstructive sleep apnea (OSA). One study reported a median reduction of 70.8% in participants' apnea-hypopnea index (AHI), which measures how often breathing stops or becomes shallow during sleep. Additionally, 82% of participants achieved an AHI below 15, indicating significant improvement. Research also indicates that this system enhances users' quality of life without causing device-related problems. These findings suggest that the Genio System is both effective and safe for treating moderate to severe OSA. Participants in this trial will receive the Genio® 2.1 System to further evaluate its effectiveness and safety. ^{1 2 3 6 7}

Who Is on the Research Team?

Jey Subarroyan, PhD

Principal Investigator

Nyxoah S.A.

Are You a Good Fit for This Trial?

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.

Your body mass index (BMI) must be 32 or lower.

My sleep study showed complete blockage at the soft palate level.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Genio® 2.1 System Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Nyxoah S.A.

Lead Sponsor

Trials

7

Recruited

460+

Nyxoah Inc.

Industry Sponsor

Trials

2

Recruited

240+

Published Research Related to This Trial

In a study involving 60 patients with obstructive sleep apnea, selective upper airway stimulation significantly reduced the apnea-hypopnea index from an average of 28.6 events per hour to 8.3 events per hour after 6 months, indicating strong efficacy in improving sleep quality.

All patients reported improvements in sleep and daytime symptoms, and there were no surgical revisions required for the implanted system, highlighting the safety of this new surgical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. Heiser, C., Maurer, JT., Hofauer, B., et al.[2022]

Ultrasonographic assessment of hyoid bone excursion (HBE) during hypoglossal nerve stimulation (HGNS) programming can effectively optimize therapy for obstructive sleep apnea, as it correlates with treatment outcomes.

In a study of 17 subjects, those who responded to HGNS (showing a significant reduction in apnea hypopnea index) had greater HBE, indicating that monitoring tongue movement can help predict and enhance the efficacy of HGNS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea With Ultrasound Assessment of Tongue Movement. Korotun, M., Quintero, L., Shikowitz, M., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eastwood, PR., Barnes, M., MacKay, SG., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea. Lewis, R., Pételle, B., Campbell, MC., et al.[2022]

In a study of 31 subjects with moderate to severe obstructive sleep apnea, hypoglossal nerve stimulation significantly reduced the severity of the condition, as shown by a decrease in the apnea-hypopnea index from 45.4 to 25.3 events per hour after 12 months.

The treatment was used regularly, averaging 5.4 hours per night, and led to improved sleep quality, with no significant adverse events occurring after the first 6 months, indicating both safety and efficacy of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. Kezirian, EJ., Goding, GS., Malhotra, A., et al.[2022]

Hypoglossal nerve stimulation (HNS) is an effective new treatment for moderate to severe obstructive sleep apnea (OSA) in patients who cannot tolerate continuous positive airway pressure (CPAP), as shown in the multicenter STAR study.

The Inspire™ system for HNS significantly improves both objective and subjective measures of OSA severity by preventing pharyngeal collapse during sleep without waking the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Upper Airway Stimulation in OSA]. Bender, B.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea]. Maurer, JT., Troia, R., Leitzbach, S.[2021]

Hypoglossal nerve stimulation (HGNS) significantly improves apnea-hypopnea indices (AHI) in patients with obstructive sleep apnea (OSA) who are intolerant to CPAP, with median AHI decreasing from 38.5 to 2.7 after treatment.

Patient characteristics such as a higher Friedman tongue position (grade IV) and Mallampati score (III/IV) were linked to a lesser response to HGNS, indicating that these measures can help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Predictors of Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. Xiao, R., Trask, DK., Kominsky, AH.[2020]

Citations

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accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf24/P240024B.pdf

SSED Template - accessdata.fda.gov

The Genio® System 2.1 is a hypoglossal nerve stimulator intended for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). It ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6949509/

Bilateral hypoglossal nerve stimulation for treatment of adult ...

Bilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05592002

NCT05592002 | Safety and Effectiveness of the Genio® ...

The solution offered by the Genio System to treat OSA patients with CCC using bilateral HGNS has a favorable risk-benefit ratio, as demonstrated by evidence ...

4.

aasm.org

aasm.org/nyxoah-receives-fda-approval-for-genio-system/

Nyxoah receives FDA approval for Genio system

Participants experienced a median AHI reduction of 70.8%, and 82% achieved an AHI below 15. The results showed Genio was effective regardless of ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611124003019

Hypoglossal nerve stimulation for obstructive sleep apnea ...

Results show that HGNS is an effective and safe treatment option. The Inspire device significantly improved, reducing the apnea-hypopnea index (AHI) by −20.14 ...

6.

neurologyadvisor.com

neurologyadvisor.com/news/fda-clears-genio-system-for-obstructive-sleep-apnea/

FDA Clears Genio System for Obstructive Sleep Apnea

The FDA has approved the Genio system for the treatment of patients with moderate to severe obstructive sleep apnea.

7.

jcsm.aasm.org

jcsm.aasm.org/doi/10.5664/jcsm.11822

Bilateral hypoglossal nerve stimulation for obstructive sleep ...

This pivotal clinical trial of HNSBL demonstrated an acceptable safety profile with clinically significant improvements in obstructive sleep apnea severity and ...