Audiodontics LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant Using novel audio hardware and specialized software this project shall research and develop a system that recognizes patterns of breath sounds within subjects who have sleep apnea hypopnea syndrome SAHS or its most serious aspect Obstructive Sleep Apnea OSA Upon completion two Phases of the project the deliverable called andquot Tooth Phone R System for Sleep Apnea Monitoring TPS SAM andquot shall be a system that on a nightly basis monitors the treatment compliance and efficacy of mandibular advancement devices MADs used to treat sleep apnea To achieve the project deliverable the Phase I has four Specific Aims They are Aim Refine the audio hardware tooth microphone previously developed and integrate the tooth microphone into an oral appliance specifically into a MAD test for safety of the andquot integratedandquot MAD and deliver several prototype data acquisition devices that record audio data from the integrated MAD Aim Test the prototype devices and integrated MAD on human subjects in a sleep lab for a SAHS event identification with audio and b human factors such as comfort and ease of use Aim Using specialized software previously developed analyze the audio tooth microphone data files recorded in the sleep lab and identify events related to SAHS Aim Contrast and compare the software results of Aim against control microphone SAHS event identifications taken during sleep lab polysomnography PSG Phase I feasibility is achieved if the identification of SAHS events by the TPS SAM system achieves a accuracy with sensitivity and specificity when compared to the CONTROL estimation provided by PSG through analysis of standard parameters by sleep doctors During Phase II the prototype shall be refined and audio data clinically correlated to standard PSG indicators of sleep apnea If successful benefits of this Project include Use of ONE sensor nightly to monitor SAHS which potentially eliminates the need for subsequent titration PSGs improves treatment efficacy and lowers cost A new stand alone system for patients at home to titrate oral appliances A system for researchers to compare the clinical effectiveness of different MAD designs An aid in long term population studies of treatment effectiveness by MADs for a specific level of OSA mild moderate severe as diagnosed by PSG not by the proposed TPS SAM and perhaps most significantly The introduction of a novel hardware platform and automated computerized method to monitor ALL breath sounds speech and non speech which in an era of Big Data and the NIH BD K initiative can lead to an entirely new way to monitor and diagnose many respiratory illnesses and pathological conditions PUBLIC HEALTH RELEVANCE This project shall deliver a new device and system for the nightly monitoring of compliance and efficacy of oral appliances that are used to treat Obstructive Sleep Apnea OSA It should lower the cost of current treatment methods that monitor OSA and it can improve the public health and transportation safety through supplying this low cost system for truck and commercial drivers who may have an OSA condition