Status:
RECRUITING
A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
Lead Sponsor:
Northwestern University
Conditions:
Dysphagia
Parkinson Disease
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.
Detailed Description
The project goal is the development and early stage validation of a wearable sensor for dysphagia in patients with PD. The first phase of the program involves engineering goals relating to increasing ...
Eligibility Criteria
Inclusion
- Inclusion criteria. Age ≥22. English speaking. Diagnosis of idiopathic Parkinson's disease of any Hoehn and Yahr stage (I-V), determined by a neurologist.
- Mild to moderate sialorrhea defined as a score of ≥ 11\* on the Radboud Oral Motor Inventory for Parkinson's Disease (ROMP)-Saliva (C) subscale Subjects must be in the "on" phase of their medication during all study assessments. The "on" phase is defined as the period when the participant's medication is at peak effectiveness, minimizing motor fluctuations and enabling optimal motor function.
- Study Exclusion Criteria. History of aspiration pneumonia within the past 12 months. Unable to swallow saliva without a maneuver. Actively receiving treatment for swallowing disorders or sialorrhea. Current alcohol/drug abuse. Diagnosed with neurological disorders other than PD. End stage dementia. History of head and neck cancer or surgery. Unable to demonstrate competency with the user-friendly sensor platform technology.
- Known allergy to contrast material used during MBSS. Known allergy to sensor adhesive. Indwelling tracheostomy tube. Nasogastric (NG) feeding tube. Currently pregnant.
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04664634
Start Date
April 1 2025
End Date
May 31 2026
Last Update
July 15 2025
Active Locations (1)
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1
Northwestern University
Evanston, Illinois, United States, 60208