Actively Recruiting

Phase 3
Age: 22Years +
All Genders
NCT04664634

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

Led by Northwestern University · Updated on 2025-07-15

60

Participants Needed

1

Research Sites

60 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 22 years or older
  • English speaking
  • Diagnosed with idiopathic Parkinson's disease at any Hoehn and Yahr stage (I-V) by a neurologist
  • Mild to moderate sialorrhea with a score of 11 or higher on the Radboud Oral Motor Inventory for Parkinson's Disease (ROMP)-Saliva subscale
  • Able to be in the "on" phase of Parkinson's medication during all study assessments, meaning medication is at peak effectiveness
Not Eligible

You will not qualify if you...

  • History of aspiration pneumonia within the past 12 months
  • Unable to swallow saliva without a maneuver
  • Currently receiving treatment for swallowing disorders or sialorrhea
  • Current alcohol or drug abuse
  • Diagnosed with neurological disorders other than Parkinson's disease
  • End stage dementia
  • History of head and neck cancer or surgery
  • Unable to use the sensor platform technology competently
  • Known allergy to contrast material used during MBSS (Modified Barium Swallow Study)
  • Known allergy to sensor adhesive
  • Presence of an indwelling tracheostomy tube
  • Presence of a nasogastric (NG) feeding tube
  • Currently pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northwestern University

Evanston, Illinois, United States, 60208

Actively Recruiting

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Research Team

A

Ankita Bhutada

CONTACT

K

Kate M Davidson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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