Treating Sleep Apnoea with IMPLANTS

Different IMPLANTS

Inspire

Inspire Hypoglossal Nerve Stimulator Implantation

The Inspire Hypoglossal Nerve Implant represents a cutting-edge solution for those suffering from obstructive sleep apnoea (OSA). This innovative, fully implantable device offers an alternative to traditional treatments by directly targeting the root cause of airway obstruction. It works by delivering gentle stimulation to the hypoglossal nerve, which is responsible for controlling the muscles of the tongue and airway. By activating these muscles, the device helps to keep the airway open during sleep, thereby preventing the collapse that leads to interrupted breathing. This results in a more natural and restful sleep experience.

The system is operated through a small, user-friendly handheld remote, allowing patients to turn the device on before bed and off upon waking. This minimally invasive treatment has been shown to significantly reduce the frequency of apnoea events, improve overall sleep quality, and enhance the patient's quality of life. Its design prioritises comfort and ease of use, making it a highly effective and appealing option for those who struggle with conventional therapies.

Nyxoah Genio

Genio Hypoglossal Nerve Stimulator Implantation

The Nyxoah Genio System is an innovative treatment designed to provide relief for those suffering from moderate to severe obstructive sleep apnoea (OSA). This unique, fully implantable device uses hypoglossal nerve stimulation to keep the airway open during sleep, ensuring uninterrupted breathing and a restful night's sleep.

Unlike traditional CPAP therapy, the Genio System is battery-free, leadless, and requires only a single incision under the chin for implantation. The device is controlled by an external activation chip, which is placed under the chin with an adhesive patch before sleep. By gently stimulating the hypoglossal nerve, the system causes a small forward movement of the tongue, preventing it from blocking the airway. This minimally invasive treatment offers a comfortable and effective alternative for those who cannot tolerate or have failed CPAP therapy, significantly improving sleep quality and overall well-being.

The Genio System is also MRI compatible and can be easily customized and upgraded without further surgery, making it a versatile and user-friendly solution for OSA patients.

An Alternative Treatment for Obstructive Sleep Apnoea
Many people find it challenging to use CPAP (Continuous Positive Airway Pressure - a mask that is used to pump air into the lungs during sleep) or Mandibular Advancement Devices (MADs - which are gum shields which are designed to pull your lower jaw forward to help you breathe behind your tongue) for treating obstructive sleep apnoea (OSA). Studies show that CPAP compliance rates can be as low as 50-60%, with many patients discontinuing use due to discomfort, inconvenience, or difficulty adjusting to the device. Similarly, while MADs are generally better tolerated, they still present issues such as jaw pain (temporomandibular joint dysfunction), dry mouth, tooth loosening. This might be too much for some patients to bear long term.

Untreated sleep apnoea can lead to a host of serious health problems. It is associated with an increased risk of cardiovascular diseases, including high blood pressure, heart attacks, and strokes. Additionally, OSA can exacerbate metabolic conditions like type 2 diabetes and contribute to weight gain. The constant interruptions in breathing during sleep result in fragmented sleep, leading to excessive daytime sleepiness, impaired cognitive function, and a higher risk of accidents. Furthermore, untreated sleep apnoea can negatively impact mental health, causing mood swings, depression, and anxiety.

Given these challenges and risks, hypoglossal nerve implants, such as the Inspire Hypoglossal Nerve Stimulator and the Nyxoah Genio System, offer a promising alternative. These fully implantable devices provide a more comfortable and less intrusive solution by directly stimulating the hypoglossal nerve to keep the airway open during sleep. By addressing this particular root cause of airway obstruction, these devices can significantly improve sleep quality and overall health, making them a viable option for those who struggle with traditional therapies.



How the Inspire Implant Works
An Inspire implant and remote control The Inspire Hypoglossal Nerve Stimulator is a fully implantable device designed to treat obstructive sleep apnoea (OSA). This system is composed of three main components: a small generator, a breathing sensor, and a stimulation electrode.

First, the generator is implanted just beneath the skin in the upper chest (a 5cm incision is made just beneath the collar bone over the 2nd rib), which is similar in size and placement to a pacemaker. The implant (which is less than 1cm in thickness is placed on top of the pectoralis muscle (the 'Pecs') and beneath the fat and skin of the chest. It is rare to be able to see this later unless your body fat levels are less than 5%). The breathing sensor is a wire that comes from the pacemaker generator and is placed between the muscles running from the 2nd and 3rd ribs. This sensor monitors when you breathe and relays that information to the compter in the implant that looks like a pacemaker.

An inspire implant and battery Another wire also coming out of the pacemaker implant travels up the neck to the front of the jawline typically on the right side. Another 5cm incision is made, and the wire is placed around the hypoglossal nerve. More precisely it is placed around certain parts of this nerve that protrude the tongue forward. It is also placed around a nerve close by called the C1 nerve which helps with stopping the epiglottis (a part of the voicebox) from blocking the airway.







When the patient is ready to sleep, they activate the device using a small handheld remote, turning it on before bedtime. The device works throughout the night by monitoring the patient’s breathing rhythm via the sensor. When it detects an attempt to inhale, it delivers gentle stimulation to the hypoglossal nerve. This stimulation prompts the tongue and surrounding muscles to move slightly forward, thus keeping the airway open and preventing the collapse that blocks breathing and causes sleep apnoea.

The stimulation is synchronised with the patient’s breathing cycle, ensuring that the airway remains clear during both inhalation and exhalation. In the morning, the patient uses the remote to turn off the device again.



How the Nyxoah Genio Implant Works

A Nyxoah genio implant and battery surgery view The Nyxoah Genio System is a pioneering fully implantable device designed to treat moderate to severe obstructive sleep apnoea (OSA). This system is made up of a compact implanted stimulator and an external activation chip.

The implanted stimulator is a small, leadless device positioned under the skin beneath the chin, through a single minimal incision. Unlike other systems, it does not require wires or an internal battery, which makes it less invasive and more comfortable. The stimulator targets the hypoglossal nerve, which controls the movement of the tongue and other essential airway muscles. Please the image which has been taken from the BLASTOSA trial published in the Eastwood PR, Barnes M, MacKay SG, et al. Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eur Respir J 2020; 55

A Nyxoah genio implant in my hand Each night before going to bed, the patient applies the external activation chip to their skin, over the implanted stimulator. This chip is held in place with a simple adhesive patch. The activation chip powers the stimulator and controls the delivery of mild, regular pulses to the hypoglossal nerve, causing the tongue and related muscles to gently move forward. This action keeps the airway open and prevents the collapse that typically causes apnoea events.

The device operates seamlessly with the patient's natural breathing rhythm, providing targeted stimulation only when needed. Upon waking, the patient removes the activation chip, stopping the stimulation and allowing them to go about their day normally.









Eligibility for the Inspire Implant

  • Moderate to severe obstructive sleep apnoea (OSA): This means the patient has an Apnoea-Hypopnoea Index (AHI) of 15–65. The AHI measures the number of apnoea (complete pause in breathing) and hypopnoea (partial reduction in breathing) events per hour of sleep.

  • PAP non-adherence: This includes patients who cannot tolerate Positive Airway Pressure (PAP) therapy, fail to achieve consistent benefit from it, or refuse to use it. This non-adherence must be documented by a healthcare provider.

  • No significant overweight (BMI ≤ 35 kg/m²): Patients should have a Body Mass Index (BMI) of 35 or less. BMI is a measure of body fat based on height and weight.

  • Percentage of central sleep apnoea ≤ 25%: Central sleep apnoea occurs when the brain does not send proper signals to the muscles that control breathing. The percentage of central sleep apnoea events should be 25% or less of the total apnoea events.

  • Other sleep disorders excluded or treated: Conditions such as Restless Legs Syndrome (RLS), which causes uncomfortable sensations and an urge to move the legs; Periodic Limb Movements (PLM), which involves repetitive movements of the limbs during sleep; and insomnia, which is difficulty falling or staying asleep, must be either excluded or adequately managed.

  • Drug-Induced Sleep Endoscopy (DISE): This procedure involves sedating the patient and observing the airway with a flexible scope to determine if they are suitable for the Inspire implant.

  • Contraindication with active implantable medical devices (AIMDs): The Inspire system is not suitable for patients who have other active implantable medical devices, such as pacemakers or defibrillators, to avoid potential device interactions.



Eligibility for the Nyxoah Genio Implant
A Nyxoah genio implant working
  • Moderate to severe obstructive sleep apnoea (OSA): The patient has an Apnoea-Hypopnoea Index (AHI) of 15–65.

  • PAP non-adherence: Patients who cannot tolerate PAP therapy, fail to benefit from it, or refuse to use it. This must be documented by a healthcare provider.

  • No significant overweight (BMI ≤ 35 kg/m²): Patients should have a BMI of 35 or less.

  • Percentage of central sleep apnoea ≤ 25%: The percentage of central sleep apnoea events should be 25% or less.

  • Other sleep disorders excluded or treated: Conditions like RLS, PLM, and insomnia must be excluded or adequately managed.

  • Contraindication with other active implantable medical devices (AIMDs): The Genio system is not suitable for patients who have other active implantable medical devices, such as pacemakers or defibrillators, to avoid potential device interactions.

One key difference between the two implants lies in the requirement for a Drug-Induced Sleep Endoscopy (DISE). The Inspire Implant necessitates this procedure, which involves sedating the patient and using a flexible scope to observe the airway, thereby assessing the patient's suitability for the implant. Conversely, the Nyxoah Genio Implant does not require a DISE procedure, which can make the evaluation process potentially simpler and less invasive for patients.








Research Articles for the Inspire Implant


The paper "Upper Airway Stimulation for Obstructive Sleep Apnea" by Strollo et al., published in the New England Journal of Medicine in 2014, evaluates the clinical safety and effectiveness of upper-airway stimulation the Inspire Upper Airway Stimulation (UAS) system. Also known as the STAR Trial

Key Findings:
An Inspire implant working

    • Effectiveness: The study demonstrated a substantial reduction in the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI). Specifically, the median AHI score decreased by 68%, from 29.3 events per hour to 9.0 events per hour (P less than 0.001). Similarly, the ODI score decreased by 70%, from 25.4 events per hour to 7.4 events per hour (P less than 0.001).

    • Improvement in Quality of Life: Secondary outcome measures, such as the Epworth Sleepiness Scale and the Functional Outcomes of Sleep Questionnaire (FOSQ), showed improvements in daytime sleepiness and overall quality of life.

    • Safety: The device was found to be safe, with no major adverse events reported during the study period.

    • Implications: This study highlights the potential of upper-airway stimulation as an alternative treatment for patients who are unable to tolerate or adhere to continuous positive airway pressure (CPAP) therapy. The results suggest that this therapy could provide a viable and effective option for managing moderate to severe OSA, thereby improving patient outcomes and quality of life.


    Overall, the paper by Strollo et al. is a well-conducted and insightful study that started the whole concept of using these devices for obstructive sleep apnoea. Since then 90,000 implants have been inserted around the world.




    Hypoglossal Nerve Stimulation Effects on Obstructive Sleep Apnea Over Time: A Systematic Review and Meta-analysis. Published Dec 20, 2023 · D. Kim Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery

    The purpose of this study was to determine how effective hypoglossal nerve stimulation (HGS) is in treating obstructive sleep apnoea (OSA). HGS is a treatment that uses a small implanted device to stimulate the hypoglossal nerve, which controls the tongue muscles, helping to keep the airway open during sleep.

    The researchers searched several online databases, including PubMed, Cochrane database, Embase, Web of Science, SCOPUS, and Google Scholar, for relevant studies. These databases are collections of scientific and medical research articles.

    They reviewed five different databases to find studies that measured various sleep-related parameters, such as the apnoea-hypopnoea index (AHI) and oxygen desaturation index. They also looked at studies that evaluated quality of life and functional outcomes before and after HGS treatment.

    • Apnoea-Hypopnoea Index (AHI): This is a measure of the number of times per hour that a person stops breathing (apnoea) or has a significant reduction in breathing (hypopnoea) during sleep.

    • Oxygen Desaturation Index: This measures how often a person's blood oxygen level drops during sleep.

    • Quality of Life and Functional Outcomes: These are measures of how the person's overall well-being and ability to function in daily life are affected by their condition and its treatment.

    A total of 44 studies, involving 8670 patients, met the criteria for inclusion. The results showed that 12 months after starting treatment:
    • About 47% of patients had an AHI less than 5 (which is considered normal, meaning they had very few breathing interruptions).

    • Approximately 72% of patients had an AHI less than 10 (indicating mild obstructive sleep apnoea).

    • Around 82% of patients had an AHI less than 15 (indicating moderate obstructive sleep apnoea).


    The clinical success rates according to Sher criteria were:

    • 80% within the first 12 months.

    • 73% between 12 and 36 months.


    The Sher criteria are a set of standards used to define successful treatment outcomes in sleep apnoea patients.

    While the positive effects of the treatment gradually decreased up to 12 months after implantation, they generally remained consistent between the 12th and 36th months.


    Conclusion
    Hypoglossal nerve stimulation (HGS) can improve the quality of life and sleep-related outcomes for patients with obstructive sleep apnoea. Although the beneficial effects gradually declined until 12 months after the implant was placed, they typically stayed stable between 12 and 36 months.

    This means that HGS can help people with obstructive sleep apnoea breathe better during sleep, which can improve their overall health and daily functioning. The positive effects are strongest in the first year but tend to remain stable after that.




    Research Articles for the Nyxoah Genio Implant


    A comparison between the DREAM Nyxoah genio implant trial and the STAR Inspire Implant

    Bilateral Hypoglossal Nerve Stimulation for Treatment of Adult Obstructive Sleep Apnoea 2020
    The study by Eastwood et al. explores the effectiveness and safety of a new bilateral hypoglossal nerve stimulation (HNS) device, called the Genio™ system, for treating obstructive sleep apnoea (OSA). This type of study is prospective, open-label, non-randomized, and single-arm, which means it looks forward in time, all participants know about the treatment they are receiving, there is no comparison group, and all participants receive the same treatment. The research was carried out across eight centres in Australia, France, and the UK, and included 27 participants, 22 of whom completed the study.

    Key Findings

    • Effectiveness: The study showed a significant reduction in the severity of OSA. The Apnoea-Hypopnoea Index (AHI), which measures the number of times per hour that a person stops breathing or has reduced breathing during sleep, decreased from 23.7 to 12.9 events per hour. The Oxygen Desaturation Index (ODI), which measures drops in blood oxygen levels, also improved, decreasing from 19.1 to 9.8 events per hour, six months after the device was implanted. These results indicate a notable decrease in OSA severity.

    • Quality of Life Improvements: Participants experienced significant improvements in daytime sleepiness, as measured by the Epworth Sleepiness Scale. They also reported better sleep-related quality of life, as assessed by the Functional Outcomes of Sleep Questionnaire-10.

    • Adherence and Safety: High adherence to the use of the device was observed, with 91% of participants using it more than five days per week, and 77% using it for more than five hours per night. Importantly, no serious adverse events related to the device were reported during the study.


    The Genio™ system's results are similar to other HNS systems but with some benefits. It offers a less invasive option with fewer implanted components and a simpler stimulation algorithm. This simplicity does not reduce its effectiveness, making it a good alternative for patients who cannot tolerate CPAP (Continuous Positive Airway Pressure) therapy.

    Conclusion
    The study concludes that bilateral HNS using the Genio™ system effectively reduces the severity of OSA and improves quality of life without significant device-related complications. This new approach offers a promising alternative for patients who cannot use traditional therapies, with high adherence and a good safety profile.





    DREAM Trial - IDE Pivotal Study for Nyxoah Genio Implant

    The DREAM Trial was designed to assess the safety and performance of a bilateral hypoglossal nerve stimulation (HGNS) system in adults with obstructive sleep apnoea (OSA). The study involved 115 participants, and it was conducted across multiple centres. This was a prospective, open-label trial, meaning that both the researchers and participants knew what treatment was being administered, and the study looked forward in time.

    Participants had to meet specific criteria to be included in the study. They needed to have an Apnoea-Hypopnoea Index (AHI) of 15 to 65, which means they experienced between 15 and 65 episodes of apnoea (complete pauses in breathing) or hypopnoea (partial reduction in breathing) per hour during sleep. Additionally, they had to be able to sleep on their back (supine position) for at least 60 minutes during their initial and 12-month sleep studies (polysomnography, or PSG).

    The study started by measuring the participants' baseline characteristics. On average, they had an AHI of 28.0 events per hour, an Oxygen Desaturation Index (ODI) of 27.0 events per hour, and a Body Mass Index (BMI) of 28.5 kg/m². The AHI and ODI are measures used to quantify the severity of sleep apnoea, with higher values indicating more severe conditions. BMI is a measure of body fat based on height and weight.

    The results of the study showed significant improvements in the participants' condition after 12 months of using the bilateral HGNS system. The responder rate, which is a measure of how many participants experienced a significant reduction in their AHI and ODI, was 63.5% for AHI and 71.3% for ODI. This means that a substantial proportion of participants had fewer breathing interruptions and drops in blood oxygen levels during sleep. The median reduction in AHI was 70.8%, showing a considerable improvement in sleep apnoea severity.

    Compliance with the treatment was high, with 85% of participants adhering to the therapy. However, there were 11 serious adverse events (SAEs) reported among ten subjects, resulting in an SAE rate of 8.7%. Out of these, three were device-related, leading to an explant (removal) of the device in three cases. The device-related SAE rate was 2.6%.

    In conclusion, the DREAM Trial demonstrated that bilateral HGNS could significantly reduce the severity of obstructive sleep apnoea and improve patients' quality of life. Although there were some serious adverse events, the overall safety profile was acceptable, and most participants complied well with the treatment. This study highlights the potential of HGNS as an effective alternative for patients with OSA who may not respond well to traditional therapies.

    It should be noted that at the time of writing this the results of this trial have not be published in a peer review article.




    Comparison of the DREAM Nyxoah Study and the Strollo STAR Inspire Study

    Study Design and Participants

    • The DREAM Trial evaluated the Genio™ system, a bilateral hypoglossal nerve stimulation (HGNS) device, involving 115 participants across multiple centres in Australia, France, and the UK. These participants had moderate-to-severe obstructive sleep apnoea (OSA) with an Apnoea-Hypopnoea Index (AHI) of 15 to 65.

    • The Strollo STAR Inspire Study assessed the Inspire Upper Airway Stimulation (UAS) therapy in 126 participants across 22 leading medical institutions in the United States and Europe. These participants also had moderate-to-severe OSA and had difficulties with CPAP therapy.


    Effectiveness:
    • The DREAM Trial showed a significant reduction in AHI from 28.0 to 12.9 events per hour and ODI from 27.0 to 9.8 events per hour at 12 months post-implantation. The responder rates were 63.5% for AHI and 71.3% for ODI.

    • The Strollo STAR Inspire Study reported a 78% reduction in AHI and an 80% reduction in ODI at 12 months. The median AHI decreased from 29.3 to 9.0 events per hour, and the median ODI decreased from 25.4 to 7.4 events per hour.


    Quality of Life Improvements:
    • In the DREAM Trial, participants experienced significant improvements in daytime sleepiness, with the Epworth Sleepiness Scale score improving from a mean of 12.5 to 5.8. They also saw improvements in sleep-related quality of life, with the Functional Outcomes of Sleep Questionnaire-10 score increasing from 14.7 to 19.6.

    • In the Strollo STAR Inspire Study, participants reported improvements in daytime sleepiness, with the Epworth Sleepiness Scale score improving from a mean of 11.6 to 6.0. The Functional Outcomes of Sleep Questionnaire score also increased from 14.4 to 18.9.


    Adherence and Safety:
    • The DREAM Trial showed high adherence, with 85% of participants using the device regularly. There were 11 serious adverse events (SAEs) reported among ten subjects, resulting in an SAE rate of 8.7%. Out of these, three were device-related, leading to the removal of the device in three cases. The device-related SAE rate was 2.6%.

    • The Strollo STAR Inspire Study also reported high adherence rates, with serious complications being less than 2%, and the improvements were maintained at 36 and 60 months.


    Conclusion
    Both studies demonstrate the effectiveness of HGNS and UAS therapies in significantly reducing the severity of OSA and improving the quality of life. The DREAM Trial showed slightly lower responder rates compared to the Strollo STAR Inspire Study, but both studies reported high adherence and acceptable safety profiles. These findings suggest that both therapies are viable alternatives for patients who cannot tolerate CPAP therapy.



    A comparison between the DREAM Nyxoah genio implant trial and the STAR Inspire Implant




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