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BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing

Award Number: R42HL176325
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2024
PERIOD OF PERFORMANCE END DATE: 09/16/2025

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BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing - Project Summary Abstract Objectives and Specific Aims: The overarching objective is to develop and validate a diagnostic tool for obstructive sleep apnea (OSA), Deep Learning-enhanced Transmembranous Electromyography (DL-tmEMG), to enable convenient point-of-care, and accurate detection of OSA for widespread use by any practitioner evaluating patients for OSA. In phase 1, this proposal aims to establish feasibility of tmEMG to diagnose OSA patients with good accuracy and to optimize the DL algorithm. Phase 2 aims to demonstrate generalizability and accuracy of DL-tmEMG in a diverse population, identifying differences in important subpopulations and the benefits of multimodal data integration, while progressing regulatory approval. Health-relatedness: This project addresses the urgent need for efficient and accurate diagnostics for OSA, a widespread and serious disorder impacting an estimated 1 billion people worldwide, while undiagnosed OSA costs the U.S. approximately $149.6 billion annually. Successful development of DL-tmEMG will enhance personalized OSA management and improve healthcare accessibility. Efficient screening for OSA in under- resourced areas and for patients pre-surgically and perinatally are relevant to this proposal. Design: Phase 1 Study#1 (9 months) is a case-control observational feasibility study of 60 adult patients. Phase 2 Study #2 (18 months) involves a large single center prospective observational cohort study of 200 adult patients referred for PSG testing at the UCSD Sleep Center. Methods: DL-tmEMG is a new diagnostic that incorporates two novel technologies: 1) a non-invasive transmembranous sensor of muscle activity (tmEMG), and 2) deep learning algorithms applied to EMG signal to provide an automatic interpretation (EMGNet). The combination of these two innovations obviates the need for an expert electromyographer, key to allowing for widespread use to fulfill the unmet need for improved diagnostics in OSA. In Phase 1 Study #1, 30 healthy and 30 patients with moderate to severe OSA will undergo DL-tmEMG within 30 days of polysomnography. We will compare DL-tmEMG classification results with PSG results and calculate performance metrics. Phase 2 Study #2 utilizes a similar methodology as Study #1 but differs in size as well as population pretest probabilities, being a cohort study design. Patients will undergo DL-tmEMG within 30 days of PSG, which will classify patients as OSA (AHI>5) or non-OSA (AHI<5). The performance of DL-tmEMG will again be compared with PSG results. Recruitment will be adjusted to allow performance to be evaluated in important sub-populations. Results of this prospective study will provide strong evidence for validity and reliability of DL-tmEMG as a novel diagnostic tool for OSA and will be used to support a multicenter study (a phase IIB proposal) that will further evaluate the performance of DL-tmEMG across sites and diverse patient populations to meet FDA submission requirements, as part of a 510(k) premarket notification or a premarket approval (PMA) process.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2024	POWELL MANSFIELD, INC.	3590 CAMINO DEL RIO N	SAN DIEGO	CA	92108	SAN DIEGO	USA	National Center on Sleep Disorders Research	000	1	3/24/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	POWELL MANSFIELD, INC.	3590 CAMINO DEL RIO N	SAN DIEGO	CA	92108	SAN DIEGO	USA	National Center on Sleep Disorders Research	000	1	4/14/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $615,621 )
2024	2024	POWELL MANSFIELD, INC.	3590 CAMINO DEL RIO N	SAN DIEGO	CA	92108	SAN DIEGO	USA	National Center on Sleep Disorders Research	000	1	9/17/2024	NEW	$615,621
														Subtotal = $615,621

Grand Total All Awards = $615,621

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BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing

Award Number: R42HL176325

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/17/2024

PERIOD OF PERFORMANCE END DATE: 09/16/2025

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