DDT-COA-000167: digital sensor for monitoring swallow count and respiratory coordination in parkinson's disease patients with dysphagia
Ended Cooperative Agreement Awarded Last action
- Award ID
- U01FD008417
- Recipient
-
Sibel Health Inc. UEI EHNPJMGCZRQ9
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $748,399
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date
- Funding agency
- Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services
- Place of performance
- Chicago, IL 60614, USA
Award details come from USAspending.gov.
Description
- Abstract
- 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.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Amendment | $249,200 | |
| Amendment | $249,200 | |
| Original award | $249,999 |
Quick answers
Who received award U01FD008417?
U01FD008417 was awarded to Sibel Health Inc. by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 1, 2024.
How much is award U01FD008417 worth?
$748,399 has been obligated on U01FD008417.
Which agency awarded U01FD008417?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD008417, with funding from Center for Drug Evaluation and Research (Food and Drug Administration).
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