Recruiting
Phase 3

Digital Therapeutic

Sponsor:

Northwestern University

Code:

NCT04664634

Conditions

Dysphagia

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Aria Sensor

Study Details

Brief summary:

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

Conditions

Dysphagia

Parkinson Disease

Study ID

NCT04664634

Start date

Apr 1, 2025

Status verified date

Aug, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Single Arm

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.

Interventions

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.

Primary outcome measure

  • Percent agreement with Gold Standard [ Time Frame: 1 year ]
  • Change in mean swallow frequency during haptic cueing week [ Time Frame: Week 1 to Week 2 ]

Central Contacts and Locations

Central contacts

Ankita Bhutada

251-622-7112ankita.bhutada@northwestern.edu

Kate M Davidson

(803) 413-2435kate.humphries@northwestern.edu

Locations

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

More Information

Sponsor

Northwestern University

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-24.