Invictus Medical, Inc. — Department of Health and Human Services SBIR Phase I: NIDCD

Description

The aural stimulation of the hospitalized infant in the neonatal intensive care unitNICUfrom alarmsventilatorsphonesconversationsand air handling system is linked to a myriad of problemsboth acute and long termThe stress resulting from the noise has a negative effect on vital signsweight gainand quality of sleep in the short term and in the long term with hearing loss and language deficitEfforts to reduce sound levels in the NICU such as staff education have not been reported in the literature to be successfulA non contact means of attenuating sound pressure levels for vulnerable infants in the NICU should reduce these harmful nosocomial effectsA prototype active noise controlANCsystem for use in an incubator has been developed that simultaneously permits parental or clinician voices to be passed through to the infant withinThis voice pass through feature is essential to ensure proper vocal developmentSuccessful deployment of this incubator based ANC system would address the clinical problems associated with excess noise while not causing a problem due to lack of adult words and conversation turnsThis Phase I work is a preliminary study to ensure that the ANC system was able to attenuate recorded NICU noises and will determine if a Phase II clinical outcome study is warranted and will improve the likelihood of a successful clinical studyUpon a successful completion of Phase Ia Phase II study would seek to demonstrate the clinical efficacy under actual conditions with patientsThe demonstration of clinical efficacy is necessary for a successful commercial launchThe proposed Phase I research is designed to determine whether a novel ANC system can attenuate sound in an incubator when exposed to simulated NICU soundsWhile a prototype system has been developed that can attenuate sine wave signalsit will be necessary to validate that the ANC system can work effectively with simulated NICU noise from recordings in a controlled environmentThe noises will include sounds found in a NICU environment including alarmsventilator soundsconversationtelephone ringsoverhead announcementsand other factors While neonatal intensive care unitsNICUshave provided enormous strides in life savingtechniques for preterm infantschallenges associated with long term developmental issues and thecost of healthcare delivery remainA system that can safely mitigate the damaging effects ofexcessive noise associated with NICU care has the potential to reduce the patientsstressresponseimprove quality of sleepspeed weight gainand reduce long term hearing lossWith thefaster weight gaina shorter length of stay is possibleimproving the financial stability ofhealthcare delivery organizations