A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's (NCT04664634) | Clinical Trial Compass
RecruitingPhase 3
A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
United States60 participantsStarted 2025-04-01
Plain-language summary
The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.
Who can participate
Age range22 Years
SexALL
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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.
What they're measuring
1
Percent agreement with Gold Standard
Timeframe: 1 year
2
Change in mean swallow frequency during haptic cueing week