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DDT-COA-000167: Digital Sensor for Monitoring Swallow Count and Respiratory Coordination in Parkinson’s Disease patients with Dysphagia

Award Number: U01FD008417
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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DDT-COA-000167: Digital Sensor for Monitoring Swallow Count and Respiratory Coordination in Parkinson’s Disease patients with Dysphagia - PROJECT SUMMARY: Parkinson’s disease (PD) presents complex challenges, including dysphagia, which affects 33-80% of patients and significantly impacts their quality of life. Dysphagia in PD is strongly linked with disease severity and can lead to severe health issues, such as malnutrition and aspiration pneumonia—a common cause of death. Additionally, up to 70% of PD patients suffer from sialorrhea, a condition exacerbated by reduced natural swallowing frequency which further complicates dysphagia by causing drooling due to saliva accumulation. Current management primarily involves rehabilitation with speech-language pathologists, yet there remains a substantial unmet need for technologies that can continuously and accurately monitor dysphagia and related symptoms in real-life settings. Existing diagnostic tools like FEES and VFS show poor correlation with patient-reported outcomes, underlining the necessity for objective measurement tools in clinical trials and therapeutic management. Sibel Health has developed the ADAM sensor, a novel wireless device designed to measure both swallowing and respiratory patterns using advanced sensor technology and machine learning algorithms. This device, placed at the suprasternal notch, has shown promise in initial studies with PD patients, demonstrating the ability to effectively monitor dysphagia and respiratory coordination. Our proposed project aims to extend this technology to support drug development by providing reliable, sensitive, and objective measurements of swallowing behavior. The comprehensive validation of the ADAM sensor will involve technical verifications such as biocompatibility and software testing, followed by clinical validations with Parkinson's patients at Northwestern University. These studies will refine the sensor's algorithms to accurately distinguish swallowing from other motor activities and validate it against established clinical standards. The broader goal of this initiative is to enhance therapeutic strategies for PD and potentially other neurological, muscular, and oncological conditions associated with dysphagia. By achieving this, we aim to facilitate the development of more effective treatments that can significantly improve patient outcomes. This proposal is aligned with the FDA's emphasis on innovative device development for managing complex diseases like Parkinson’s.


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	2025	SIBEL HEALTH INC.	2017 NORTH MENDELL ST	CHICAGO	IL	60614	COOK	USA	Food and Drug Administration Research	000	2	1/15/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $249,200 )
2025	2025	SIBEL HEALTH INC.	2017 NORTH MENDELL ST	CHICAGO	IL	60614	COOK	USA	Food and Drug Administration Research	000	2	9/18/2025	NON-COMPETING CONTINUATION	$249,200
														Subtotal = $249,200

Issue Date FY: 2024 ( Subtotal = $249,999 )
2024	2024	SIBEL HEALTH INC.	2017 NORTH MENDELL ST	CHICAGO	IL	60614	COOK	USA	Food and Drug Administration Research	000	1	9/2/2024	NEW	$249,999
														Subtotal = $249,999

Grand Total All Awards = $499,199

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DDT-COA-000167: Digital Sensor for Monitoring Swallow Count and Respiratory Coordination in Parkinson’s Disease patients with Dysphagia

Award Number: U01FD008417

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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