No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
60 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease who have trouble swallowing. Participants will use a wearable sensor to help with these issues during the study.
Are You a Good Fit for This Trial?
Rules you outEnd stage dementiaOther neurological disorders
You may be able to join if
I am at least 22 years old
I speak English
I have been diagnosed with Parkinson's disease
I have mild to moderate drooling problems
I am stable on my medication during the study
You may not be able to join if
I had aspiration pneumonia in the past 12 months
I cannot swallow my saliva without help
I am currently receiving treatment for swallowing problems
I have a history of head or neck cancer or surgery
I cannot use the sensor platform technology
I have a tracheostomy tube
I am currently pregnant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.
Trial Locations
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City
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Status
Eligibility Criteria
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 …
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.
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