Sonica LLC — Department of Health and Human Services STTR Phase I: NICHD

Description

Preterm birthPTBdelivery prior toweeks gestational ageaccounts forof all births and remains the leading cause of neonatal deathThe majority of PTB is preceded by spontaneous preterm laborPTLCurrentlythere is a major unmet need for methods to identify women at risk of PTL and provide an early warning system for potential interventionhome uterine monitoringHUMis one approach that has shown some promise as an early warning system for PTLHowevera critical limitation of HUM relies on bulkyand wired equipmentThusthis system only allowed for transient monitoring in a sedentary stateandlthours per dayFurthermoreolder HUM trials utilized tocodynamometrypressureNewer evidence suggests that electromyographyEMGbased measurements for uterine activity offer superior predictive power and are less influenced by body habitusAlthough continuous measurement of other physiological parameters such as heart rateheart rate variabilitysleep efficiencytemperatureand blood pressure may hold additional predictive value for spontaneous PTL beyond uterine monitoring alonethe predictive ability of the combination of these measures has not been evaluatedThe ability to cost effectivelycomprehensively and continuously measure a variety of physiological parameters in the home settingand relate these parameters to spontaneous PTLremains unexploredIn this proposalwe will modify our existing wirelessultra thinflexibleand miniaturized vital signs monitoring system composed of a time linked chest patchlimb patchand abdominal patchandltmm in thicknessfor home useThe chest unit includes alead ECGheart rateaccelerometerphysical activitysleep qualityrespirationand temperature sensorThe limb patch incorporates a photoplethysmographPPG for SpOTogetherthe chest and limb sensor is able to provide a non invasive continuous measurement of blood pressureBPby calculating pulse arrival timePATLastlythe abdominal patch unit includes an ultra low noise continuous EMG for the continuous sensing of uterine contraction frequencyamplitude and propagation velocityThese sensors can be applied without the presence of a health care professione ganalogous to applying a bandaidWe hypothesize that a low burdenwirelessand wearable monitoring system that allows continuous measurement of multiple physiologic parameters will allow improved and earlier detection of PTL in high risk women Preterm birthPTBdelivery prior toweeks gestational ageaccounts forof all births at a cost of more than $billion USDs annually and remains the leading cause of neonatal deathThe majority of PTB is preceded by spontaneous preterm laborPTLCurrentlythere are limited technologies and tools that can accurately predict PTLWe propose the development of a wirelessand wearable monitoring system that allows continuous measurement of multiple physiologic parameters that will allow improved and earlier detection of PTL in high risk women