Obstructive sleep apnea (OSA) is a prevalent debilitating disease characterized by periods of suffocation during sleep and increased risk of heart failure and stroke. Current diagnostic methods are effective at identifying the disease but provide little guidance in selecting among treatment options. IFOS has developed innovative sensor technology, and is proposing to develop a device that measures pressure within the airway and can locate blockages. The device will provide a new diagnostic data to the sleep professional ? location information about the airway collapse. The availability of this data to a treating physician offers guidance in selecting treatment options while retaining compatibility with current diagnostic practices. In candidates for surgical intervention, for example, an upper airway collapse observed in the palatal region indicates consideration of uvulopalatopharyngoplasty or radiofrequency ablation of the soft palate, while lower level obstructions indicate different interventions such as radiofrequency ablation of the tongue or maxillomandibular advancement. The research will measure each of the four criteria for a successful program: (1) sensitivity (confirming airway obstruction every time indicated by polysomnography); (2) specificity (distinguishing apnea events from hypopnea events); (3) definiteness (providing unambiguous information on location of airway collapse); and (4) effectiveness (improving the treatment of sleep apnea patients. The proposed device offers benefits for patients, physicians and technicians. For the patient, the new sensor offers greater comfort during polysomnography due to the smaller diameter and lighter weight of the IFOS sensor. For the sleep technician, insertion, monitoring, and removal procedures remain unchanged because we retain the stiffness and elasticity of existing manometry cannulas. Physicians will be empowered to make better treatment choices and create better outcomes. The replacement of existing manometers with IFOS sensors aims at improving patient outcomes and cuts costs, thus providing better clinical economies. The IFOS team has an excellent track record in the development of fiber-optic sensor networks for biotechnology applications. We are working closely with esteemed medical professionals from the UCSF- Stanford Health Services Sleep Clinic to ensure that the program stays focused on the right objectives and achieves a high level of success.

Public Health Relevance

ATTACHMENT) IFOS proposes a low-cost, durable, disposable, accurate, networkable pressure sensing array would be ideal for real-time mapping of airway obstructions in patients suffering from impaired breathing, particularly for use in the treatment obstructive sleep apnea (OSA). This Phase I research aims to demonstrate the feasibility of a novel integrated distributed pressure micro sensor platform, consisting of an interrogation system and an array of fiber optic sensors, to accurately and comfortably diagnose OSA and aid in treatment choice.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HL147650-01
Application #
9774962
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Brown, Marishka
Project Start
2019-09-23
Project End
2020-09-22
Budget Start
2019-09-23
Budget End
2020-09-22
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Intelligent Fiber Optic Systems Corp
Department
Type
DUNS #
877452664
City
Santa Clara
State
CA
Country
United States
Zip Code
95054