A device the size of a matchbox will help treat obstructive sleep apnea

Current treatment is limited and uncomfortable

Patients currently have two options for treating sleep apnea: The first and most widespread are CPAP (continuous positive airway pressure) full-face masks, which prevent airway obstruction by creating positive pressure in the airways. However, many patients find them uncomfortable, and some even find them humiliating. Every second patient eventually abandons the mask.

The second option is implanted hypoglossal nerve stimulators, which clear the airways by arching the tongue. However, due to high costs and the need for a surgical procedure, where an electrode is implanted in the patient's face and a battery in the chest, this method is also not very popular.

Dr. Williamson's team decided to combine the advantages of both devices and designed the FitSleep device, which works on a similar principle as hypoglossal nerve stimulators. No surgical procedure is necessary in this case, and it is also a cost-effective method, making the device much more accessible and patient-friendly.

How the device works

The device operates on the principle of bilateral temporal interference. It is a non-invasive method in which electrodes placed on the skin stimulate the hypoglossal nerve (nervus hypoglossus), which controls tongue movement. By emitting an electric field at specific frequencies, the tongue is pushed forward, preventing airway obstruction during sleep.

Until now, hypoglossal nerve stimulation required a surgical procedure. "The hypoglossal nerve is located under a layer of muscle, making it difficult to target with standard non-invasive stimulation. Through bilateral temporal interference, however, we can limit the impact on adjacent tissues and affect only this nerve by exposure," explains Dr. Williamson.

Patients will install this device, about the size of a matchbox, according to simple instructions each night before going to bed and keep it in the same place throughout the night. The device is designed to be comfortable and not disrupt the user's sleep routine. Initial signs of sleep improvement and a reduction in apnea episodes should appear within a few weeks of continuous use. A longer-term effect should be noticeable after several months. More detailed data on efficacy and its time frame will be known only after the ongoing clinical studies are completed.

Fig. 1 Patients attach the FitSleep device under the lower jaw before going to bed and leave it there throughout the night. Photo: Somnial Technologies

When will the device be available to patients?

The project is currently in the phase of clinical testing with a selected group of patients. Clinical tests are primarily focused on the safety and efficacy of the device and are crucial for confirming its therapeutic benefit and obtaining all necessary approvals.

Exactly when the device will be available to a broader range of patients depends on the results of ongoing studies, the speed of regulatory processes, and manufacturing capabilities. According to Dr. Williamson, the goal is to bring the device to market as soon as possible, with a realistic timeframe of three years.

(jko)

Source: A device the size of a matchbox is set to revolutionize the treatment of sleep apnea. Masaryk University, 18 Jan 2024. Available at: www.muni.cz/pro-media/tiskove-zpravy/pristroj-velikosti-krabicky-od-sirek-ma-prinest-revoluci-v-lecbe-spankove-apnoe