NCT04664634 · Northwestern University
A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
What this study is about
The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.
View original scientific description
The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Evanston, Illinois
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2025 · Source of record for eligibility and locations