|

A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's

RECRUITINGPhase 3Sponsored by Northwestern University
Actively Recruiting
PhasePhase 3
SponsorNorthwestern University
Started2025-04-01
Est. completion2026-05-31
Eligibility
Age22 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT04664634

Summary

The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.

Eligibility

Age: 22 Years+Healthy volunteers accepted
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.

Conditions3

DysphagiaParkinson DiseaseParkinson's Disease

Locations1 site

Northwestern University
Evanston, Illinois, 60208
Kate Davidson

Browse More Trials

Parkinson's Disease trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.