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

NCT04664634 | Recruiting Phase 3

• 1 other identifier: STU00221904
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in algorithm-detected swallow frequency during haptic cueing week

  Week 1 to Week 2

• Change in Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) score

  Baseline to Week 3

• Change in ROMP-Swallowing Subscale score

  Baseline to Week 3

• Change in participant adherence to haptic cueing

  Week 2

Other Outcomes (2)

• Change in Modified Barium Swallow Impairment Profile (MBSImP)

  Baseline to Week 3

• Change in Penetration-Aspiration Scale Score

  Baseline to Week 3

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

Aria Sensor DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Parkinson Disease

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Ankita Bhutada

CONTACT

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

Kate M Davidson

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: April 1, 2025
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)