Project Summary Few medical disorders have a larger public health impact than Obstructive Sleep Apnea (OSA). OSA affects more than 20 million people in the US alone, and when untreated, it is associated with significant comorbidities and mortality. Current diagnostic tests for OSA, however, are expensive, inconvenient, and largely ineffective. Overnight in-facility sleep studies, also known as polysomnography (PSG), show low patient compliance and limited sensitivity and specificity, largely due to the anatomical complexity of OSA. Drug-induced sleep endoscopy (DISE) can provide additional information on the type and location of obstruction, but it requires direct involvement of a trained otolaryngologist and anesthesia professional. Furthermore, its reliability is limited due to the subjective nature of the findings. In short, a safe, portable, and efficient instrument for rapid characterization of obstructive airway physiology would find wide use in the assessment of patients with suspected obstructive sleep apnea. This system would benefit millions of patients by providing critical information to aid in the determination of the best therapy for OSA in a particular patient. We believe that the multi-sensor catheter system we are proposing can serve this role. Bold Type is developing the “SmartCatheter” system, a wireless, cloud-connected, multi-sensor catheter and tablet app designed to provide rapid evaluation of upper airway obstruction to diagnose obstructive sleep apnea (OSA). We hypothesize that: (1) an innovative system for measuring and analyzing acoustic and pressure along the upper airway can be developed; (2) that combined data from acoustic and pressure sensors will be sensitive to obstruction presence, location, type, and degree; and (3) that algorithms can be developed to convert raw acoustic and pressure data into summary metrics that facilitate the diagnosis of obstructive sleep apnea. We propose the following Specific Aims: In Aim 1, we will develop a SmartCatheter system composed of a wireless, naso-esophageal multi-sensor catheter to record dynamic acoustic pressure and static pressure along the upper airway, and a tablet app to communicates wirelessly with the catheter, perform algorithms on acoustic and pressure waveforms, provide visual feedback to the user, and transfer data to a database for storage and analysis. In Aim 2, we will develop preliminary diagnostic algorithms capable of detecting the presence, location, type, and degree of obstruction in an airway simulator. And in Aim 3, we will conduct a limited proof-of-concept human study using the system developed in Aim 1 with 5 healthy controls and 5 OSA patients to gather preliminary human data and evaluate acoustic and pressure differences between the two groups. Upon successful completion of these three aims, we will be well poised to pursue a Phase 2 SBIR project geared toward developing a commercialization ready SmartCatheter system and validating it in a multi-site study comparing performance against PSG and DISE.

Project Narrative Obstructive sleep apnea (OSA) affects more than 20 million people in the US alone, and when untreated, it is associated with significant comorbidities and mortality. Current diagnostic tests are expensive, inconvenient, and largely ineffective. Bold Type is developing the “SmartCatheter” system, a wireless, cloud-connected, multi- sensor catheter and tablet app designed to provide rapid evaluation of upper airway obstruction. This system will reduce the cost and effort required to diagnose OSA, while providing better information on the location, type, and severity of obstructions to aid in the selection of treatment.