la Administración de Drogas y Alimentos de EEUU (FDA) dio luz verde a la comercialización de un nuevo dispositivo destinado a reducir los ronquidos y la apnea obstructiva leve del sueño. El eXciteOSA, que puede obtenerse solo con receta médica, se utiliza de manera diurna a diferencia de otros equipos que también operan a través de la estimulación eléctrica en la lengua. Está destinado a mejorar la función de los músculos de la lengua, lo que con el tiempo puede ayudar a evitar que la lengua se colapse hacia atrás y obstruya las vías respiratorias durante el sueño.
El dispositivo eXciteOSA (https://exciteosa.com) funciona proporcionando estimulación muscular eléctrica a través de una boquilla que se coloca alrededor de la lengua. La boquilla tiene cuatro electrodos, dos ubicados sobre la lengua y dos ubicados debajo de la lengua. Este artefacto envía una serie de pulsos eléctricos con periodos de descanso intermedios. Se usa -estando despierto- durante 20 minutos una vez al día, durante un 6 semanas y una vez a la semana a partir de entonces.
La FDA evaluó la seguridad y eficacia del dispositivo en 115 pacientes con ronquidos, incluidos 48 pacientes con ronquidos y apnea del sueño leve. Todos los pacientes usaron el dispositivo durante 20 minutos, una vez al día durante 6 semanas, luego interrumpieron su uso durante 2 semanas antes de ser reevaluados. En general, el porcentaje de tiempo dedicado a roncar a niveles superiores a 40 dB se redujo en más del 20% en 87 de los 115 pacientes. En un subconjunto de 48 pacientes con ronquidos y AOS leve, el IAH medio se redujo en un 48%, de 10,21 a 5,27, en 41 de 48 pacientes. Los eventos adversos más comunes observados fueron salivación excesiva, molestias en la lengua o los dientes, hormigueo en la lengua, sensibilidad al empaste dental, sabor metálico, arcadas y mandíbula apretada.
Si bien es un equipo de reciente lanzamiento, el cirujano inglés Vik Veer presentó un review de este equipo en junio de 2020. El reporte (que el experto señala no fue pagado por los fabricantes) plantea que este dispositivo es una alternativa que puede ser de utilidad en casos de pacientes cuya lengua es grande, carece de tono muscular y no se hayan afectados por otras morbilidades o patologías del sueño.
El eXciteOSA se suma al amplio catálogo de productos centrados en la monitorización del sueño a través de tecnología wearable que interactúa con el teléfono celular, entre ellos smartwatchs, colchones, almohadas y pijamas que buscan prevenir la obstrucción obligando al usuario a cambiar de posición al dormir.
El eXciteOSA es un producto de Signifier Medical Technologies, LLC. EEUU.
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