The main treatment options for obstructive sleep apnea (OSA) are continuous positive airway pressure therapy (CPAP) and mandibular advancement devices. CPAP has a 15% initial refusal rate and long term adherence is difficult to achieve. 30% of the patients are not suitable for mandibular advancement devices. Another treatment option is surgery, which is invasive, so correlated with perioperative and postoperative complications. The most common sleep apnea surgical procedure is the uvulopalatopharyngoplasty, which has highly variable success rates
OSA affects 4% of the population. It causes severe fatigue during the day and is associated with high blood pressure, arrhythmia, stroke and heart failure. There is a medical need for more non-invasive treatment options.
75% of patients showed an improvement in apneas or hypopneas while using the device. Thereafter, the design and algorithm of the device is optimized to further increase the treatment efficacy. The size of the device decreased and the algorithm automatically adapts the stimulation to the patient’s needs. The next step will be validation of this new prototype in clinical trials, obtaining CE mark/FDA approval, so it can be implemented in the clinical setting.
The solution is a non-invasive device that detects, monitors and treats obstructive sleep apnea using kinesthetic stimulation. The device consist of a cardiorespiratory recorder, a kinesthetic stimulator and a real-time processing algorithm.