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SCH: Smart Breath- based Diagnosis of Pulmonary Exacerbations in Children with Cystic Fibrosis through Machine Learning: Towards Noninvasive Health Monitoring in Real-Time

Award Number: R01HL177812
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/09/2024
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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SCH: Smart Breath- based Diagnosis of Pulmonary Exacerbations in Children with Cystic Fibrosis through Machine Learning: Towards Noninvasive Health Monitoring in Real-Time - Cystic fibrosis (CF) is a genetic disorder that negatively affects young people across the globe. Pulmonary exacerbations (PEx), episodes of decreased lung function accompanied by coughing, increased sputum production, and weight loss, are a hallmark of CF lung disease. Besides negative health impacts, PEx comes with a burden to healthcare costs in the United States and beyond ($10K-$40K USD per episode). Although PEx can be treated with antibiotics, patients still experience decreased quality of life and ultimately reduced survival. A point-of-care, rapid, and accurate test to identify impending PEx that would benefit from treatment could have an impact on families of children with CF and their clinicians through reducing misdiagnosis and overtreatment. Breath testing, through identifying volatile organic compound (VOC) biomarkers, holds great promise for the development of home-based/clinical testing solutions for PEx. The goal of this research is to develop a hand-held smart sensor system that can detect exhaled VOC biomarkers for PEx noninvasively in real-time. To accomplish this, machine learning will be utilized to identify a breath-based biosignature of PEx (Aim 1). In parallel, the team will design/test a nanosensor array to detect the biosignature (Aim 2) and develop a user-friendly smartphone app to be used at-home or in the clinic (Aim 3). Ultimately, this research will further the development of diagnostic solutions for PEx, and advance knowledge in a multi-faceted fashion across disciplines including basic science, chemistry, engineering, medicine, biotechnology, and health informatics. The technological solution is highly disruptive and challenges the current paradigm of how PEx is diagnosed. From an engineering perspective, sensors are at the cusp of being translated into biomedical devices, and this research aims to overcome challenges in selectivity that can also be leveraged for VOC-based diagnosis of other heart and lung diseases beyond CF. The interdisciplinary team has vast experience in their respective fields, and their collaboration ensures successful completion of the research. A diverse set of resources/equipment from the team's laboratories, along with others on campuses, will be leveraged to support research activities. RELEVANCE (See instructions): The research addresses


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 = $284,311 )
2026	2026	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Lung Diseases Research	000	3	7/22/2026	NON-COMPETING CONTINUATION	$284,311
														Subtotal = $284,311

Issue Date FY: 2025 ( Subtotal = $385,931 )
2025	2025	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Lung Diseases Research	002	2	9/15/2025	NON-COMPETING CONTINUATION	$292,276
2025	2024	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Lung Diseases Research	001	1	7/14/2025	NEW	$300,000
2025	2024	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Lung Diseases Research	000	1	7/9/2025	NEW	-$206,345
														Subtotal = $385,931

Issue Date FY: 2024 ( Subtotal = $206,345 )
2024	2024	TRUSTEES OF INDIANA UNIVERSITY	980 INDIANA AVE RM 2232	INDIANAPOLIS	IN	46202	MARION	USA	Lung Diseases Research	000	1	9/9/2024	NEW	$206,345
														Subtotal = $206,345

Grand Total All Awards = $876,587

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SCH: Smart Breath- based Diagnosis of Pulmonary Exacerbations in Children with Cystic Fibrosis through Machine Learning: Towards Noninvasive Health Monitoring in Real-Time

Award Number: R01HL177812

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/09/2024

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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