Genio Bilateral Stimulation for Obstructive Sleep Apnea

(ACCCESS Trial)

Recruiting at 14 trial locations

Overseen By Brendan McBrine

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

124 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 3 7 8}

Research Team

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.

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

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

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+

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.

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea]. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Preoperative Predictors of Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Optimization of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea With Ultrasound Assessment of Tongue Movement. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Upper Airway Stimulation in OSA]. [2018]