Genio Bilateral Stimulation for Obstructive Sleep Apnea (ACCCESS Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Nyxoah S.A.
No Placebo Group
Approved in 3 jurisdictions
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.
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.12458
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.45678
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.34578
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.
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.
I cannot or will not use PAP treatments for my condition.
I am between 22 and 75 years old and not under legal guardianship.
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.
I haven't had surgeries or treatments that could affect a new sleep apnea device.
Treatment Details
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.
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
Research locations nearbySelect from list below to view details:
Hospital of the University PennsylvaniaPhiladelphia, PA
Bogan Sleep Consultants, LLCColumbia, SC
PharmaDev Clinical Research Institute,Miami, FL
Vanderbilt University Medical CenterNashville, TN
More Trial Locations
Loading ...
Who is running the clinical trial?
Nyxoah S.A.Lead Sponsor
Nyxoah Inc.Industry Sponsor
References
Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. [2022]Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnea pathogenesis. Hypoglossal nerve stimulation activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce obstructive sleep apnea severity. The objective of this study was to examine the safety, feasibility and efficacy of a novel hypoglossal nerve stimulation system (HGNS; Apnex Medical, St Paul, MN, USA) in treating obstructive sleep apnea at 12 months following implantation. Thirty-one subjects (35% female, age 52.4 ± 9.4 years) with moderate to severe obstructive sleep apnea and unable to tolerate positive airway pressure underwent surgical implantation and activation of the hypoglossal nerve stimulation system in a prospective single-arm interventional trial. Primary outcomes were changes in obstructive sleep apnea severity (apnea-hypopnea index, from in-laboratory polysomnogram) and sleep-related quality of life [Functional Outcomes of Sleep Questionnaire (FOSQ)]. Hypoglossal nerve stimulation was used on 86 ± 16% of nights for 5.4 ± 1.4 h per night. There was a significant improvement (P
[Upper Airway Stimulation in OSA]. [2018]Anatomical basis of obstructive sleep apnea (OSA) is the collapse of the pharynx during sleep. It is considered as a result of complex interactions of structural and neuromuscular factors. Depth of sleep and body position have modulating effects. Although different areas of obstruction were identified, studies show that the sleep-mediated obstruction frequently occurs in the base of tongue area.Continuous positive airway pressure (CPAP) is the standard treatment for obstructive sleep apnea syndrome (OSAS) since more than 30 years. In several studies, treatment compliance was approximately 70%. So CPAP intolerance requires alternative surgical and non-surgical treatments.Functional electrical stimulation of upper airway muscles was investigated in the early 1980s. Studies have shown that stimulation of certain muscle groups increases the upper airway lumen. The major role of the hypoglossal nerve in upper airway obstruction was detected. The XII. cranial nerve innervates the genioglossus muscle, which stabilizes the anterior oropharynx substantially. Whereas a complete stimulation of the nerve leads to co-activation of other muscles including constrictors, the selective stimulation of anterior nerve branches causes advancement of the genioglossus.For hypoglossal nerve stimulation (HNS), the Inspire™ system and the ImThera™ device are currently approved in Europe. After extensive studies in animals and clinical examination of the concept of hypoglossal nerve stimulation (HNS), the results of the multicenter, prospective STAR study (Stimulation Therapy for Apnea Reduction) with the Inspire system were recently published. This study revealed that HNS can prevent the pharyngeal collapse without waking up the patient from sleep. The HNS with this device resulted in a significant improvement of both objective and subjective parameters of the severity of OSA.Electrical stimulation of the hypoglossal nerve is a new treatment for patients with moderate to severe OSA, who do not tolerate standard treatment.
Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. [2022]Objective Selective stimulation of the hypoglossal nerve is a new surgical therapy for obstructive sleep apnea, with proven efficacy in well-designed clinical trials. The aim of the study is to obtain additional safety and efficacy data on the use of selective upper airway stimulation during daily clinical routine. Study Design Prospective single-arm study. Setting Three tertiary hospitals in Germany (Munich, Mannheim, Lübeck). Subjects and Methods A multicenter prospective single-arm study under a common implant and follow-up protocol took place in 3 German centers (Mannheim, Munich, Lübeck). Every patient who received an implant of selective upper airway stimulation was included in this trial (apnea-hypopnea index ≥15/h and ≤65/h and body mass index <35 kg/m2). Before and 6 months after surgery, a 2-night home sleep test was performed. Data regarding the safety and efficacy were collected. Results From July 2014 through October 2015, 60 patients were included. Every subject reported improvement in sleep and daytime symptoms. The average usage time of the system was 42.9 ± 11.9 h/wk. The median apnea-hypopnea index was significantly reduced at 6 months from 28.6/h to 8.3/h. No patient required surgical revision of the implanted system. Conclusion Selective upper airway stimulation is a safe and effective therapy for patients with obstructive sleep apnea and represents a powerful option for its surgical treatment.
Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. [2021]Label="BACKGROUND AND AIM">Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system.
Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea. [2022]This report describes the surgical implantation of a novel bilateral hypoglossal nerve stimulator (Genio system®, Nyxoah S.A., Belgium) and the successful treatment of a patient with moderate obstructive sleep apnea (OSA).
Preoperative Predictors of Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. [2020]Hypoglossal nerve stimulation (HGNS) is an effective treatment for patients with obstructive sleep apnea (OSA) who fail continuous positive airway pressure (CPAP). We assessed the relationship between patient characteristics and response to HGNS.
Optimization of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea With Ultrasound Assessment of Tongue Movement. [2022]Hypoglossal nerve stimulation (HGNS) is an Food and Drug Administration-approved therapy for obstructive sleep apnea. Initial programming of HGNS is based on the observation of anterior tongue movement, which may not reflect opening at the retroglossal airway. We developed an ultrasonographic technique to assess the base of tongue movement with HGNS to be used to optimize the initial voltage settings.
[Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea]. [2021]Reduced genioglossus muscle tone is considered one of the major causes for obstructive sleep apnea (OSA). Hypoglossal nerve stimulation (HNS) keeps the upper airway patent by increasing the muscle tone of the genioglossus muscle being the major airway opener. According to the German S3-Guideline on Sleep Disordered Breathing this treatment is indicated in patients with OSA failing or rejecting positive airway pressure, showing an AHI between 15 and 65, in particular when anatomy is normal and the BMI below 35. In 2021 it has been made available for regular patient care in Germany. However, breathing synchronized, continuous, and bilateral HNS differ in parts relevantly regarding their patient selection criteria, technical features, surgical technique, therapy setting and programming, and daily use for the patient. There are many publications showing the safety, efficacy, and patient satisfaction of breathing synchronized HNS. Less but promising data are available for continuous and the most recent bilateral HNS.