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

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

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Dysphagia
• Intervention / Treatment: Device: Aria Sensor

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ankita Bhutada; Phone Number: 251-622-7112; Email: ankita.bhutada@northwestern.edu
• Study Contact Backup: Name: Kate M Davidson; Phone Number: (803) 413-2435; Email: kate.humphries@northwestern.edu

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Recruiting
      • Northwestern University
      • Contact: Kate Davidson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Parkinson's Disease

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent agreement with Gold Standard	Percent agreement between experimental sensor Gold standard (GS) respiratory inductance plethysmography (RIP) with Inductotrace System®, Ambulatory Monitoring)	1 year
Change in mean swallow frequency during haptic cueing week	This outcome measures the change in the average number of swallows per hour during the intervention week (Week 2, with haptic cueing) compared to baseline (Week 1, no cueing). Swallows will be manually labeled from sensor audio recordings by at least three independent annotators.	Week 1 to Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in algorithm-detected swallow frequency during haptic cueing week	This outcome measures the change in the mean swallow frequency as automatically detected by the Aria sensor's AI algorithm, comparing Week 2 (intervention) to Week 1 (baseline). Performance will be benchmarked against manually annotated swallows.	Week 1 to Week 2
Change in Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) score	Assesses the effect of the intervention on drooling symptoms using the Sialorrhea Clinical Scale for PD. Participants complete this validated questionnaire at baseline, during, and after the intervention.	Baseline to Week 3
Change in ROMP-Swallowing Subscale score	Assesses changes in self-reported swallowing function using the Swallowing Subscale of the Radboud Oral Motor Inventory for Parkinson's Disease (ROMP). The ROMP is a validated, PD-specific measure.	Baseline to Week 3
Change in participant adherence to haptic cueing	Evaluates adherence to the intervention by quantifying the percentage of haptic cues that are followed by a swallow within 5 seconds during Week 2. Cue-swallow pairings are based on algorithmic and manual labeling.	Week 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Barium Swallow Impairment Profile (MBSImP)	Subsample of participants will undergo video fluoroscopy to evaluate swallowing function. The MBSImP scores will assess changes in swallow physiology pre- and post-intervention.	Baseline to Week 3
Change in Penetration-Aspiration Scale Score	Assesses airway protection during swallowing via penetration-aspiration scale scores from videofluoroscopic studies in a subsample of participants.	Baseline to Week 3

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Mouth Diseases; Stomatognathic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Salivary Gland Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Sialorrhea
• Other Study ID Numbers: STU00221904

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No