SBIR-STTR Award

?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 "Tooth Phone(R) System for Sleep Apnea Monitoring (TPS-SAM)", 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 1) 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 "integrated" MAD, and deliver several prototype data acquisition devices that record audio data from the integrated MAD; (Aim 2) 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 3) Using specialized software previously developed, analyze the audio (tooth microphone) data files recorded in the sleep lab and identify events related to SAHS; (Aim 4) Contrast and compare the software results of Aim 3 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 85% accuracy (with 88 % sensitivity and 70 % 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: (1) Use of ONE sensor nightly to monitor SAHS, which potentially eliminates the need for subsequent titration PSGs, improves treatment efficacy, and lowers cost, (2) A new stand-alone system for patients at home to titrate oral appliances, (3) A system for researchers to compare the clinical effectiveness of different MAD designs, (4) 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, (5) 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 - BD2K initiative, can lead to an entirely new way to monitor and diagnose many respiratory illnesses and pathological conditions.

Public Health Relevance Statement:


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.

NIH Spending Category:
Bioengineering; Clinical Research; Dental/Oral and Craniofacial Disease; Lung; Networking and Information Technology R&D; Patient Safety; Sleep Research

Project Terms:
Age; base; Big Data; Breathing; Chest; Clinical effectiveness; Compliance behavior; Computer Analysis; Computer software; computerized; Continuous Positive Airway Pressure; cost; Data; data acquisition; Data Analyses; Data Files; Dental; design; Development; Device Designs; Devices; Diagnosis; Diagnostic; Event; Future; Gender; Goals; health record; Home environment; Hour; Human; human subject; improved; Institutional Review Boards; Investigation; Laboratories; Lead; Learning; Mandibular Advancement; Masks; Medical; Methods; Minor; Modification; Monitor; novel; Obstructive Sleep Apnea; Oral; Patients; Pattern; Phase; Physiological; Polysomnography; Population Study; prototype; public health medicine (field); public health relevance; Questionnaires; Records; Reporting; Research; Research Personnel; respiratory; respiratory health; Respiratory Sounds; Safety; safety testing; screening; sensor; Sleep; Sleep Apnea Syndromes; Small Business Innovation Research Grant; software development; sound; Specificity; Speech; Speech Sound; Surveys; Syndrome; System; Techniques; Telephone; Testing; Time; Titrations; Tooth structure; Training; Transportation; Treatment Effectiveness; Treatment Efficacy; United States National Institutes of Health; Weight