NIH Reporter #1R44HL187056-01

REST- Respiratory Ear System for CPAP Therapy adherence

Award to Stealth Labs Inc. for developing and testing the Dreambuds System, an intra-ear device to improve CPAP therapy adherence in obstructive sleep apnea patients, including feasibility studies and economic analysis.

Description

Obstructive sleep apnea (OSA) affects up to 40% of US adults, leading to significant cardiometabolic comorbidities. Treatment with continuous positive airway pressure (CPAP) improves sleepiness and health outcomes but faces adherence challenges, with up to 80% nonadherence. The Dreambuds System, developed by Stealth Labs, is an innovative intra-ear device with sensors that measure intra-ear heart rate, accelerometry, and heart rate variability. Using AI algorithms, it detects sleep onset, measures sleep stages and quality, and delivers tailored sounds to improve sleep. Preliminary data shows high acceptance and feasibility. The project aims to customize Dreambuds to enhance CPAP adherence through qualitative interviews (Phase 1), demonstrate feasibility, and conduct a randomized controlled trial (Phase 2). An economic analysis will assess cost-effectiveness and potential healthcare system integration.

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