Sibel Inc. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

1 PROJECT SUMMARY: andgt;50% of adults aged 65+ have a high risk of obstructive sleep2 apnea (OSA), a condition that increases the risk of stroke, heart attack, and death. The3 prevalence of OSA is at least twice as high in older adults compared to younger age4 groups. Despite this increased risk and prevalence, only 8% of older adults at high risk5 of OSA receive evaluation by either in-laboratory polysomnography (PSG) or home6 sleep apnea testing (HSAT). Accessing sleep laboratories for PSG is burdensome for7 older adults given their frailty or dependence on others. While there are several FDA-8 approved HSAT devices that allow for diagnosis of OSA in the home setting9 unmonitored—these systems remain a significant challenge to operate for older adults 10 given the multitude of wires, chest bands, and nasal cannulas required for setup. As 11 such, the reported sensor loss and technically inadequate recordings occur in up to 30% 12 of cases. Currently, there is no existing technology designed explicitly for older adults 13 that can cost-effectively, comprehensively, and unobtrusively measure the wide range of 14 physiological parameters necessary in diagnosing OSA. In this proposal, we will modify 15 our existing wireless, flexible, and miniaturized vital signs monitoring system–composed 16 of a chest patch and finger patch that recapitulate the form factor of a Band-Aid. The 17 chest unit has a continuous 1-lead ECG (heart rate, heart rate variability), accelerometer 18 (respiratory rate, chest wall movement, inspiratory effort, body position, sleep time, 19 snoring time), bio-impedance (respiratory rate) and temperature sensor. The limb patch 20 incorporates a photoplethysmograph (PPG for SpO2). Together, the chest and limb 21 sensor captures an advanced measurement: pulse arrival time (PAT) and pulse transit 22 time (PTT). PAT/PTT waveforms have been shown to detect sleep arousal events, 23 quantify inspiratory effort, differentiate central from obstructive apnea, and identify 24 patients in need of nasal CPAP. Applying these sensors involve simply removing an 25 adhesive liner prior to placement. We will develop a new, ultra-simplified user interface 26 on the iPad that follows best practices for those with low technical literacy, visual 27 impairments, or hearing impairments. We hypothesize that a low-burden, wireless, and 28 wearable monitoring system that allows for continuous measurement of multiple 29 physiologic parameters specific to sleep in a highly comfortable form factor will facilitate 30 diagnosis and treatment of OSA in older adults.PROJECT NARRATIVE andgt;50% of adults aged 65+ are at high risk for obstructive sleep apnea (OSA), a condition that increases the risk of stroke, heart attack, depression, and death. However, only 8% of older adults at high risk of OSA receive evaluation by existing systems. Currently, there is no existing technology designed explicitly for older adults for diagnosing OSA at home. We propose the development of a low-burden, wireless, and wearable monitoring system designed explicitly for older adults to facilitate greater identification and treatment of OSA in this vulnerable population.