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Non-Contact Point of Care Device for Sleep Studies

Award Number: R44AG060779
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2014
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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Non-Contact Point of Care Device for Sleep Studies - Project Summary/Abstract Proposed is an easy-to-use, non-contact, wearable-free, portable method for the diagnosis of obstructive sleep apnea (OSA) with heart rate, breath rate, and sleep stage monitoring for use in clinical or home settings. Such a system has the potential to also be used for longitudinal monitoring of sleep during interventions. In this Phase IIB effort, the team will complete the evaluation and testing required to bring this product to market. The work also responds to the Notice of Special Interest (NOSI), “Validation of Digital Health and Artificial Intelligence/Machine Learning Tools for Improved Assessment in Biomedical and Behavioral Research.” Significance: An estimated 54 million Americans have sleep apnea, and recent epidemiological studies indicate the prevalence of this disorder is on the rise. OSA is associated with several negative health outcomes including depression and type 2 diabetes. Currently, polysomnography (PSG) is the gold standard test for diagnosis of OSA. PSG systems are complex. They typically require a skilled technician for setup and continuous monitoring to ensure the accuracy of results thereby limiting their use to sleep clinics. However, recent reviews of access to sleep clinics have found supply of OSA diagnostic services is not always able to meet demand. Home sleep apnea test (HSAT) systems do exist, however, like current PSG systems, they employ sensing modalities that suffer from issues of miscalibration or diminished efficacy as the user moves through the night. Sensors typically used by HSAT systems (nose-worn cannula, EEG, plethysmography belts, etc.) must be in direct contact with the patient and are wired to a central recorder that the patient must wear. Patients report that worn/wired sensors are uncomfortable and, in some cases, affect their sleep quality. These issues present a barrier to effective diagnosis of OSA for many populations including the un/under-insured, rural populations, individuals with accessibility needs, those with developmental disabilities, and children. Hypothesis: It is hypothesized that an easy-to-use wearable-free device capable of sensing standard measures of sleep apnea severity (AHI), heart rate, respiratory rate, and sleep stages will make diagnosis available to several populations underserved by current PSG and HSAT technology, thereby increasing the quality of life for those individuals affected by OSA and other conditions. Specific Aims: In the Phase II effort, the proposed sensing technology was demonstrated to be exceptionally effective. In Phase IIB, the following aims are proposed: 1) Finalize technology integration, manufacturing, and test product for commercial readiness, 2) Conduct human subject trial to assess device accuracy compared to gold-standard truth source.


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: 2025 ( Subtotal = $1,546,575 )
2025	2025	INNOVATIVE DESIGN LABS INC	861 E HENNEPIN AVE STE 450	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Aging Research	000	4	9/19/2025	COMPETING CONTINUATION	$1,546,575
														Subtotal = $1,546,575

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2019	INNOVATIVE DESIGN LABS INC	861 E HENNEPIN AVE STE 450	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Aging Research	000	3	1/12/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	INNOVATIVE DESIGN LABS INC.	861 E HENNEPIN AVE STE 450	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Aging Research	000	3	6/14/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	INNOVATIVE DESIGN LABS INC.	861 E HENNEPIN AVE STE 450	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Aging Research	000	3	6/11/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $795,332 )
2019	2019	INNOVATIVE DESIGN LABS INC.	861 E HENNEPIN AVE STE 450	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Aging Research	000	3	5/31/2019	NON-COMPETING CONTINUATION	$795,332
														Subtotal = $795,332

Issue Date FY: 2018 ( Subtotal = $702,958 )
2018	2018	INNOVATIVE DESIGN LABS INC.	861 E HENNEPIN AVE STE 450	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Aging Research	000	2	8/27/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$702,958
														Subtotal = $702,958

Grand Total All Awards = $3,044,865

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Non-Contact Point of Care Device for Sleep Studies

Award Number: R44AG060779

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2014

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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