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

Northwestern University

Status and phase: Enrolling; Phase 3

Conditions: Dysphagia; Parkinson Disease

Treatments: Device: Aria Sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT04664634

STU00221904

Details and patient eligibility

About

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

Full 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 the battery life of this sensor to 48 hours between charges and reducing the overall form factor size. The second phase of the program is to conduct focus groups with PD patients to assess sensor usability, set up burden, and design feedback. The third phase of the study will assess the feasibility of the sensor to detect and cue swallowing in a small cohort of PD patients.

Enrollment: 60 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Single Arm

Experimental group

Description:

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.

Treatment:

Device: Aria Sensor