Actively Recruiting
A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
Led by Northwestern University · Updated on 2025-07-15
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are developing and validating a wearable sensor designed to help patients with Parkinson's Disease (PD) who have swallowing difficulties and drooling problems. This study focuses on improving the device's battery life and size, assessing usability with patient feedback, and testing its ability to detect and encourage swallowing in PD patients. The aim is to provide a digital therapeutic platform that can support swallowing function in this population. The wearable device, called the Aria sensor, is a patch that monitors physiological signals continuously and provides vibratory haptic cues to increase how often participants swallow. Participants will use the sensor for three weeks, with the device actively providing haptic cues only during the second week. This single-arm study tracks how the sensor performs in real-life conditions without randomization or blinding. Participants will be involved for three weeks, during which researchers will measure swallow frequency changes, participant adherence to using the haptic cues, and changes in clinical scales related to drooling and swallowing. Assessments include comparing sensor data to a gold standard and evaluating symptom severity before and after the intervention. The study also includes focus groups to gather patient feedback on usability, and safety monitoring is conducted throughout the study period.
CONDITIONS
Brief Title
A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- English speaking
- Diagnosis of idiopathic Parkinson's disease of any Hoehn and Yahr stage (I-V) confirmed by a neurologist
- Mild to moderate sialorrhea defined by a score of 11 or higher on the Radboud Oral Motor Inventory for Parkinson's Disease (ROMP) Saliva subscale
- Must be in the "on" phase of medication during all study assessments
You will not qualify if you...
- History of aspiration pneumonia within the past 12 months
- Unable to swallow saliva without a maneuver
- Currently receiving treatment for swallowing disorders or sialorrhea
- Current alcohol or drug abuse
- Diagnosed with neurological disorders other than Parkinson's disease
- End stage dementia
- History of head and neck cancer or surgery
- Unable to demonstrate competency with the sensor platform technology
- Known allergy to contrast material used during MBSS
- Known allergy to sensor adhesive
- Presence of an indwelling tracheostomy tube
- Presence of a nasogastric feeding tube
- Currently pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants wear the Aria sensor patch continuously for 3 weeks. During the second week, the sensor provides active vibratory haptic cues to increase swallow frequency.
1 baseline visit and weekly check-ins during the 3-week period
Trial Site Locations
Total: 1 location
1
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
Research Team
A
Ankita Bhutada
K
Kate M Davidson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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