NCT04664634CompletedPhase 3
A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 6 Dec 2020
- Start date
- 1 Apr 2025
- Primary completion date
- 9 Oct 2026
- Lead sponsor
- Northwestern University
- Diseases
- Parkinson disease
- NCT number
- NCT04664634
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 59
- From 1 Apr 2025 to the primary completion date, 9 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.