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

> **NIH FDA U01** · SIBEL INC. · 2024 · $249,999

## Abstract

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.

## Key facts

- **NIH application ID:** 11088667
- **Project number:** 1U01FD008417-01
- **Recipient organization:** SIBEL INC.
- **Principal Investigator:** Shuai Xu
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $249,999
- **Award type:** 1
- **Project period:** 2024-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11088667

## Citation

> US National Institutes of Health, RePORTER application 11088667, DDT-COA-000167: Digital Sensor for Monitoring Swallow Count and Respiratory Coordination in Parkinson’s Disease patients with Dysphagia (1U01FD008417-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/11088667. Licensed CC0.

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