Descripción del proyecto
Un pequeño avance hacia la detección sistemática del autismo
El diagnóstico temprano del autismo es esencial. Si se interviene antes de los 2 años de edad, el índice de éxito alcanza un 90 %, frente al 11 % cuando se supera la edad de 5. SensPD controla un problema habitual del autismo, la percepción sensorial, midiendo las emisiones otoacústicas. Este procedimiento es objetivo, breve, no invasivo y puede realizarse ya horas después del nacimiento. El procedimiento de SensPD se incluirá en las pruebas que se realizan de forma estándar a todos los neonatos para facilitar una intervención temprana. En el proyecto SensPD, financiado con fondos europeos, se llevarán a cabo tres estudios clínicos en múltiples ubicaciones para determinar la viabilidad tecnológica. La colaboración con una empresa de dispositivos de emisiones otoacústicas permitirá la inclusión de SensPD en sus productos como complemento. El equipo de SensPD, posteriormente, realizará estudios clínicos multiubicación más extensos y ofrecerá la prueba como un dispositivo de control en línea de las intervenciones.
Objetivo
About 1 in 45 babies born today will be diagnosed later in life with Autism Spectrum Disorder (ASD). But final diagnosis will come only at age four, too late for early interventions that would allow them to markedly improve their level of functionality, enabling them to acquire needed social skills to be integrated in society. When interventions are applied before the age of two the outcome is an over 90% success rate of social integration, as compared to after the age of five, where the success rate drops below 11%.
People with ASD in all its forms have Sensory Processing (SP) issues, SensPD monitors SP performance by measuring the Oto-Acoustic Emissions (OAE). This procedure is objective, short, non-invasive and can be performed hours after birth. SensPD aims to include this procedure in the standard battery of tests performed on every new-born, enabling early interventions, and realizing the cost savings associated with this improved functionality.
During Phase I, SensPD will complete the technological and economic feasibility of the device and the service. SensPD will conduct three small scale clinical studies, each with 30 diagnosed subjects between the ages of two to five and 30 controls. The readings will be compared with results of the current diagnoses, thus establishing the technological feasibility. SensPD’s economic viability will be tested from the perspective of using the device as an add-on to an already existing OAE measuring device (and not as a stand-alone device). We will negotiate with an OAE device company as a strategic partner and complete the approval of the patent in Europe and USA.
In Phase II, SensPD will conduct widened multi-site clinical studies (~250 subjects per site), will start the regulatory process and the establishment of a cloud global data base. By the completion of the clinical trials, the process for obtaining the needed regulatory approvals, as well for obtaining the insurance reimbursement code, will be underway.
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SMEInst-2018-2020-1
Régimen de financiación
SME-1 - SME instrument phase 1Coordinador
3601201 Kiryat Tivon
Israel
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.