RecruitingPhase 3NCT04664634

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

Sponsor

Northwestern University

Enrollment

60 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Dysphagia

Summary

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

Eligibility

Min Age: 22 Years

Inclusion Criteria1

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.

Exclusion Criteria1

Known allergy to contrast material used during MBSS. Known allergy to sensor adhesive. Indwelling tracheostomy tube. Nasogastric (NG) feeding tube. Currently pregnant.

Interventions

DEVICEAria Sensor

The Aria sensor is a wearable patch that continuously monitors physiological signals and provides vibratory haptic cues to increase swallow frequency. The intervention consists of using the sensor over a 3-week period, with active haptic cueing during Week 2 only.