| Popis: |
Hypoglossal Nerve Stimulation (HGNS) can decrease Obstructive Sleep Apnea (OSA) severity via tongue contraction and decreased upper airway collapsibility and thus be an alternative for patients who do not tolerate Positive Airway Pressure. To assess the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HGNS to treat OSA: the Genio™ system, a prospective, open-label, non-randomized, single arm treatment study was conducted at eight centers in three countries (Australia, France, UK). Primary outcomes were the incidence of device-related Serious Adverse Events (SAEs) and change in the Apnea-Hypopnea Index (AHI). The secondary outcome was the change in the 4% Oxygen Desaturation Index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring, and device use. From 27 implanted participants (63% male, aged 55.9±12.0 years, BMI 27.4±3.0 kg/m²), 22 completed the protocol. At 6 months, AHI decreased from 23.7±12.2 to 12.9±10.1, a mean change of 10.8 events/hr [p 5 days per week, and 77% reported use for >5 hours per night. No device-related SAE occurred during the 6-months post-implantation period. In conclusion, bilateral HGNS using the Genio™ system can reduce OSA severity and improve quality of life with an acceptable safety profile. |
