In France, sleep apnea affects nearly 4% of the population. It is important to treat this syndrome as soon as it is diagnosed, because it seriously impacts health. Standard treatment involves sleeping with a continuous positive airway pressure (CPAP) machine. Nyxoah, a Belgian company specializing in sleep quality, has developed an alternative device, called Genio. It is a neurostimulation device, which is more comfortable to use than CPAP machines.
Sleep apnea is a common and serious disorder that causes brief interruptions in breathing (apneas). It results from the relaxation of the muscles in the walls of the throat, which tighten, sometimes to the point of complete obstruction. When apnea occurs, the brain causes a micro-awakening to restart breathing. Untreated patients can experience several dozen to several hundred apneas per night! They are not aware of it, especially since many people are unaware that they are affected.
This sleep disorder has significant social and medical consequences. Due to repeated micro-awakenings, sleep is less restorative. As a result, daytime sleepiness may occur, leading to an increased risk of road or work accidents. This permanent fatigue can also lead to difficulty concentrating, as well as mood disorders. Finally, sleep apnea induces a high risk of cardiovascular and metabolic disorders. Not forgetting the loud snoring (which can reach 70 to 100 dB!) which is a real nuisance for the partner.
A face mask that is sometimes difficult to tolerate
Overweight and obesity are among the factors predisposing to the development of sleep apnea. First of all, patients must therefore improve their lifestyle in order to reduce their BMI. Most patients also use a CPAP machine. This machine sends a flow of air, through a face mask, to keep the airways open (and thus prevent the pharynx from collapsing).
Sleeping with a mask connected to a machine all night, however, is relatively uncomfortable. This is why many patients end up giving up CPAP after a few months of use. A new type of device, called Genio, which is based on neurostimulation, could suit them better.
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Nyxoah is a medical technology company developing revolutionary treatment alternatives for obstructive sleep apnea. They designed the Genio system for people who cannot tolerate or refuse continuous positive airway pressure ventilation. This device provides bilateral stimulation of the hypoglossal nerve – the nerve that innervates all the muscles of the tongue. Several studies have shown that hypoglossal nerve stimulation is a very effective alternative therapy, to which patients adhere more easily.
Stimulation of this nerve causes a muscular contraction that “pushes” the tongue forward. This prevents the tongue from “falling” backwards and blocking the upper airways.
The system consists of a neurostimulator, implanted under the chin via a small incision. Its electrodes are placed in contact with the two branches of the hypoglossal nerve. It is controlled by an external activation chip, fixed under the chin overnight using an adhesive patch. During the day, the patient removes the patch and recharges the chip. No batteries, sensors, or wires are implanted in the body.
A quick and painless procedure
Genio is designed to adapt to the patient's anatomy and weighs only 3 grams. Placed approximately 2.5 cm under the skin, it is not palpable. Patients can adjust the stimulation level and monitor their sleep using a smartphone app.
This implant received CE marking in March 2019 and is approved for use in Europe. For the first time in the United Kingdom, a patient with obstructive sleep apnea recently benefited from this device. The procedure took place this month, at University College London Hospitals NHS Foundation Trust (UCLH). The operation, which lasts approximately two hours, consists of making a 6 cm incision under the chin, then placing the implant at the level of the hypoglossal nerve.
The patient, Natalie Boller, 63, recovered very quickly from the procedure. She must return to the clinic to have the device activated in the coming weeks. She told British news agency PA Media that she was looking forward to being more active, to no longer feeling tired all the time.
On December 4, Natalie Boller received a bilateral hypoglossal nerve stimulation implant to treat obstructive sleep apnea from which she has suffered for ten years. Credits: Lucy North/PA
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She said she “tried everything” to relieve her symptoms, including a CPAP machine. “ I tried the PPC for a whole year, changing masks trying to find something that fit me, but I couldn't seem to feel comfortable. I was staying up half the night trying to fall asleep with this mask on my face », she relates.
Patients eligible for this therapy must have moderate to severe sleep apnea. This means their apnea/hypopnea index (AHI) is between 15 and 65. They must also have tried using a CPAP machine without success. Finally, their body mass index must be less than 35. Studies have indicated that nerve stimulation may be less effective in cases of severe obesity.
A choice of treatments for greater patient comfort
Note that UCLH already proposed the installation of another nerve stimulator: the Inspire implant, designed in 2007 by the American company Inspire Medical Systems. Olivia Rushton, 48, was the first patient to benefit from it in the United Kingdom. She had the surgery in June and her doctors activated the device a month later. She returned to UCLH this month for a sleep analysis. The number of his apneas decreased by 62%. On average, Inspire therapy reduces the number of apneas by 79% according to the official website.
The installation and design of the Inspire system are slightly different. The installation requires two incisions, one under the jaw and one in the chest. The stimulator is installed near the collarbone; a wire connects it to one side of the hypoglossal nerve, usually the right. Patients can control the intensity of stimulation using a remote control.
In both cases, the recovery time is relatively quick (24 to 48 hours) compared to other sleep surgeries, which may involve reconstruction of the palate and removal of parts of the tongue. “ Patients typically experience pain for four to six weeks, with potential changes in swallowing, speaking, and feeling in the back of the throat. says Dr Ryan Chin Taw Cheong, ENT consultant and sleep surgeon from UCLH. Conversely, the placement of the implants did not cause any discomfort or pain.
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These two devices can therefore constitute an excellent alternative to CPAP devices. “ We are very pleased to be the first hospital in the UK to offer a choice of Hypoglossal Nerve Stimulators “, declared the specialist. “ This new technology will allow us to offer an effective personalized treatment option to a wide range of patients, as each implant has unique characteristics that can be tailored to the patient's needs. “, he added.
Dr Cheong nevertheless regrets that sleep apnea is currently largely underdiagnosed in women. This disorder is generally considered to be typically male, when in fact it is common in both sexes. Because women are often underrepresented in clinical trials, there is limited data regarding the diagnosis and treatment of sleep apnea in women. However, they present “particular anatomical and physiological particularities, to which attention should be paid,” underlines the surgeon.
With an unwavering passion for local news, Christopher leads our editorial team with integrity and dedication. With over 20 years’ experience, he is the backbone of Wouldsayso, ensuring that we stay true to our mission to inform.
