What side effects are associated with this type of intervention?

The most common treatments for Obstructive Sleep Apnea (OSA) include positive airway pressure (PAP) therapy, oral appliances, and hypoglossal nerve stimulation (HGNS). PAP therapy can cause side effects such as nasal congestion, dry mouth, and skin irritation from the mask. Oral appliances may lead to jaw discomfort, dental misalignment, and excessive salivation. Hypoglossal nerve stimulation, including systems like the Genio System, can cause side effects such as tongue soreness, dry mouth, and mild discomfort at the stimulation site. Overall, these treatments are generally well-tolerated, but patients should discuss potential side effects with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Obstructive Sleep Apnea (OSA), including continuous positive airway pressure (CPAP) devices and oral appliances. While the Genio System, which uses bilateral hypoglossal nerve stimulation (HGNS) to prevent airway collapse, is being studied, a similar FDA-approved treatment is the Inspire Upper Airway Stimulation (UAS) therapy. This device also stimulates the hypoglossal nerve to maintain airway patency during sleep. Other pharmacologic treatments and surgical options are available, but HGNS represents a significant advancement in the management of OSA.

What other types of research exist?

Promising novel alternatives to the Genio System for OSA patients include: 1) Electrical stimulation systems targeting the vagus nerve, which aim to suppress neural communication between the brain and the stomach to promote weight loss and potentially reduce OSA symptoms. 2) Intragastric balloon systems, which create a sensation of satiety and may aid in weight reduction, indirectly improving OSA. 3) Miniaturized, endoscopically-delivered gastric stimulators that enhance slow wave regularity and amplitudes, potentially improving gastric emptying and reducing OSA symptoms. 4) Percutaneous electrode systems for temporary neurostimulation, which may offer a less invasive option for managing OSA symptoms.

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Device

Genio Bilateral Stimulation for Obstructive Sleep Apnea (ACCCESS Trial)

N/A

Recruiting

Research Sponsored by Nyxoah S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe OSA (15≤AHI4≤65 where combined central and mixed AHI<25% of the total AHI) based on a screening HST and confirmed in Baseline PSG.

Complete concentric collapse at the level of the soft palate based on screening DISE.

Must not have

Diagnosed psychiatric disease (e.g., psychotic illness, uncontrolled major depression or acute anxiety attacks) that prevents participant compliance with the requirements of the investigational study testing.

Major anatomical or functional abnormalities that would impair the ability of the Genio® System to treat OSA: Craniofacial abnormalities narrowing the airway or the implantation site, Palatine tonsil size 3+ or 4+ by the Brodsky Classification, Fixed upper airway obstructions (tumor, polyps, nasal obstruction), Congenital malformations in the airway, Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion), Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire, Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the duration of the study is expected to be approximately 4.5 years.

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include typical surgical complications such as infection or reaction to anesthesia. There could also be device-specific issues like discomfort at the implant site or unintended nerve stimulation effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe sleep apnea confirmed by tests.

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

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I cannot or will not use PAP treatments for my condition.

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I am between 22 and 75 years old and not under legal guardianship.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a psychiatric condition that stops me from following study procedures.

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I do not have major airway or swallowing issues that would affect the Genio® System's effectiveness.

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You have serious health conditions that make surgery or anesthesia risky, such as severe heart problems, uncontrolled high blood pressure, or certain neurological disorders.

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I haven't had surgeries or treatments that could affect a new sleep apnea device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the duration of the study is expected to be approximately 4.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the duration of the study is expected to be approximately 4.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the duration of the study is expected to be approximately 4.5 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint

Trial Design

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obstructive Sleep Apnea (OSA) work by preventing airway collapse during sleep. Continuous Positive Airway Pressure (CPAP) uses a machine to deliver a constant stream of air through a mask, keeping the airway open. Oral appliances reposition the jaw and tongue to maintain airway patency. Hypoglossal Nerve Stimulation (HGNS), such as the Genio System, involves stimulating the hypoglossal nerve to activate tongue muscles, thereby preventing airway collapse. This is particularly important for OSA patients as it directly addresses the muscle tone loss that contributes to airway obstruction, offering an alternative for those who cannot tolerate CPAP or oral appliances.

Rehabilitation of patients with obstructive sleep apnea syndrome.