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NIH grant 1R44HL187056-01: REST- Respiratory Ear System for CPAP Therapy adherence
Institute: {'code': 'HL', 'abbreviation': 'NHLBI', 'name': 'National Heart Lung and Blood Institute', 'admin_org_id': '12500068', 'admin_funding_url': ''}. PI: Yadid Ayzenberg. Award: $306864.
Start: 2026-09-05T00:00:00.
ABSTRACT
Obstructive sleep apnea (OSA) is a highly prevalent condition affecting up to 40% of Americans. Development
of OSA results in poor sleep quality, increased apnea/hypopnea episodes during sleep and subsequent
development of cardiometabolic diseases like hypertension, coronary artery disease and diabetes. Excessive
daytime sleepiness and impaired concentration due to poor sleep in individuals with OSA can result in
decreased workplace performance, increased risk of motor vehicle accidents and lower productivity. Overall,
the economic impact related to increased medical care and decreased productivity exceeds $150 billion per
year in the US. OSA is treated through lifestyle changes to decrease obesity, the most common etiology of
OSA, as well as the use of Continuous Positive Airway Pressure (CPAP) machines that help reduce
apnea/hypopnea at night. While access to CPAP machines is improving, adherence continues to be
challenging. Empirical data suggests that up to 80% of patients will be nonadherent to CPAP, and the average
nightly use in individuals is approximately 4-5 hours, while >6 hours of CPAP use per night is needed to
experience cardiovascular benefits. Additionally, adherence tends to decline without support with cohort
studies demonstrating that only about 50% of individuals with OSA will remain adherent to their CPAP at one
year. Importantly, adherence in the first 2-4 weeks of CPAP use is predictive of long-term adherence. There is
therefore a critical need to develop interventions to maximize CPAP adherence among those with OSA. In
response, Stealth Labs has developed the Dreambuds System, a highly innovative earphone with integrated
sensor package that measures intra-ear heart rate, accelerometry and heart rate variability. Through artificial
intelligence algorithms, the Dreambuds detect sleep onset, and measure sleep stage and quality overnight.
Based on sleep stage, different sounds can be delivered to the headphones to facilitate improved sleep
overnight. A paired app allows users to access their data and sleep metrics. Our preliminary data
demonstrates that individuals are accepting of wearing Dreambuds to help with sleep, and a beta study of
N=25 users demonstrated that individuals will wear the Dreambuds and record sleep data over the course of
one week. Inspired by this data, this SBIR Fast Track proposal will now customize the Dreambuds to address
CPAP adherence among individuals with OSA using key informant qualitative interviews in phase 1. We will
end phase 1 by demonstrating feasibility of the Dreambuds system among individuals with OSA on CPAP. In
phase 2, we will conduct a randomized controlled trial to measure the effectiveness of Dreambuds to improve
CPAP adherence compared to treatment as usual among individuals with OSA newly starting CPAP. Finally,
we will pair our clinical trial results in phase 2 with an economic analysis to measure the economic impact and
benchmark the cost of Dreambuds within the healthcare system. The overall impact of this fast track proposal
will be to advance the Dreambuds system and develop commercialization avenues for Stealth Labs.
OMB No. 0925-0001/0002 (Rev. 03/16 Approved Through 10/31/2018) Page Continuation Format Pagedocument fetched 2026-09-10 22:51