SBIR-STTR Award

It is proposed to develop a software system for collecting, monitoring, analyzing, reporting, and archiving polysomnography data of infants and children. The project will collect pediatric polysomnography data from sleep clinics; it will include the design of a tool for measuring the amplitude and duration of each wave in a waveform in EEG, EOG, EMG and respiratory data. The tool will include a graphical user interface to facilitate the input and output of waveform criteria and measurement results. The tool will be used to determine waveform criteria to be used for the automated analysis of pediatric polysomnography data. The sleep parameters of pediatric subjects differ significantly from those of the adult population. A separate sleep state classification system is used for patients less than one year of age. The proposed work will include the development of a system for categorizing and reporting on the sleep of these very young subjects. A database management system will be designed during the Phase II research. A multi-laboratory verification and validation study will also be conducted in the Phase II research. A significant portion of the pediatric population has sleep disordered breathing; it has been estimated as in excess of 2% of the pediatric population has sleep disordered breathing. Thus, the project has a strong likelihood of leading to a commercial success.

Thesaurus Terms:
computer program /software, computer system design /evaluation, pediatrics, polysomnography electroencephalography, electromyography, electrooculography, sleep child (0-11), clinical research, human data, infant human (0-1 year)

Polysomnography, the advent in the 1950s of an objective means of recording and analyzing sleep, greatly accelerated progress in the scientific description of sleep, including the establishment of age-sex norms. In the 1980s, polysomnography enabled the discovery and description of obstructive sleep apnea, a relatively common condition having co-morbidities such as hypertension, stroke, diabetes, epilepsy, and possibly some variants of Alzheimer's disease, as well as detrimental effects on waking cognitive function and mood. During the past two decades, the marriage of relatively inexpensive desktop computers to polysomnography has spawned the field of digital/computerized polysomnography (cPSG). While cPSG has offered indubitable advantages over its analog predecessor in terms of the flexibility and ease of data display and editing, as well as in space requirements and cost of data archival, cPSG provides a decreased accuracy of its data representation/analysis and display on the 30 second computer monitor screen. The proposed work offers the possibility of a third paradigmatic advance in polysomnography-an originally conceived software system that builds upon technological advances of the past decade in computer hardware and software, enabling accurate representation, display, analysis, report generation, and archival of the core dynamic sleep waves and waveforms of children's (and adults') sleep, while maintaining capability of providing traditionally computed "sleep architecture" macroparameters for pediatric and adult sleep. Our completed Phase I work successfully performed bench work development and validation of the system's foundational waveform detection and analysis tools for the accurate representation, display, and analysis of the delta waves of pediatric sleep. The Phase II work will extend this development to all of the primary waves and waveforms of pediatric sleep, additionally scaffolding the development to a tool permitting accessing of PSG data from multiple hardware platforms and in multiple data formats, and to a powerful but relatively inexpensive database management module offering customized data archival. The innovative system development will be validated by bench testing and by a sleep lab validation study of its automated analysis capability. The system's capabilities far exceed the capabilities offered by commercially available systems, auguring an enormous commercial potential.

Thesaurus Terms:
computer data analysis, computer program /software, computer system design /evaluation, computer system hardware, pediatrics, polysomnography, sleep biomedical automation, computer graphics /printing, online computer, patient monitoring device, sleep disorder clinical research, human data