Phase II year
2015
(last award dollars: 2017)
Phase II Amount
$1,439,876
Mobile multifunctional tool for monitoring and management of respiratory diseases Chronic Obstructive Pulmonary Disease (COPD) and asthma affect millions of people worldwide. Because there is no permanent cure for these diseases, efficient management of the patients is needed. New mobile health technologies, such as personal devices that allow patients to monitor their diseases under or near free- living conditions, will lower the cost, and thus contribute to the solution of the problem. Furthermore, continuous monitoring of the patients' health status afforded by the mobile devices will provide more complete information than the sporadic medical exams carried out currently in hospital or clinical settings. The most effective diagnosis and management technologies for COPD and asthma are spirometry and capnography. However, traditional low-cost spirometers are relatively inaccurate and lack of gas exchange information, and the capnography equipment is bulky, expensive, and difficult-to-operate without close supervision of professionals. These factors have limited spirometry and capnography to the use in hospital or clinic setting only. The present project aims at developing a personal device that can perform both capnography and spirometry for patients to use outside of hospitals and clinics. Creating such a device has been a challenge. To overcome the challenge, the Phase 1 part of the project has successfully developed and validated several innovations, including 1) a nanocomposite sensing material for accurate breath-by- breath analysis of carbon dioxide concentrations, 2) a low cost and high performance acoustic flow sensor that covers a wide dynamic range for both low flow-rate capnography and high flow-rate spirometry, 3) an adaptive sampling algorithm for correctly collecting the patient's breath without the presence of professionals, and 4) a cell phone application for signal processing. Building upon the success of Phase 1, this Phase 2 project will transform the technology into a real world solution for COPD and asthma patients by designing, building and testing a complete device with cell phone App, establishing manufacturing protocols, and preparing a FDA application. The project will bring together strengths of the sensor development and device fabrication at TF Health Co (doing business as Breezing Co.), sensor characterization and testing team at ASU, and clinical expertise of Banner Good Samaritan Medical Center to achieve the goal. The team has worked together and completed all the milestones in Phase 1, and is ready to overcome technical challenges and to develop the first wireless device with both spirometry and capnography capabilities.
Public Health Relevance Statement: Public Health Relevance: A pocket-sized mobile multifunctional device capable of both capnography and spirometry will be developed, tested and validated. The device is designed for more efficient management and more effective treatment of millions of patients with chronic respiratory diseases, including asthma and chronic obstructive pulmonary disease.
Project Terms: Acoustics; Affect; Algorithms; American; Asthma; asthmatic patient; Back; Breath Tests; Businesses; Capnography; Carbon Dioxide; Cellular Phone; Certification; Chest; Chronic; Chronic Obstructive Airway Disease; Clinical; Clinics and Hospitals; Communication; Computer software; consumer product; cost; Current Procedural Terminology Codes; Data Display; Data Storage and Retrieval; design; Detection; Device or Instrument Development; Devices; Diagnosis; Discrimination (Psychology); Disease; effective therapy; Electromagnetics; Equipment; Gases; Goals; Guidelines; handheld mobile device; Health; Health Status; Health Technology; Hospitals; Humidity; Immune; Industry; innovation; instrument; Insurance; Life; Light; Lighting; Lung diseases; Marketing; Measurement; Measures; Medical; Medical center; Medical Device; meetings; mHealth; Monitor; nanocomposite; Patient Monitoring; Patients; Performance; Phase; Population; pressure; Production; Protocols documentation; public health relevance; pulmonary function; quality assurance; Quality Control; Reaction Time; Receiver Operating Characteristics; Relative (related person); Risk Assessment; Safety; Sales; Sampling; Sensitivity and Specificity; sensor; signal processing; Societies; Solutions; Spirometry; success; Supervision; Technology; Temperature; Test Result; Testing; tool; usability; user-friendly; verification and validation; Wireless Technology; Work
