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 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.

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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Northwestern University

Evanston, Illinois, United States, 60208