NCT04664634

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Dysphagia
• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Aria 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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2020-12-11
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States