Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04664634

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dysphagia Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Otorhinolaryngologic Diseases Parkinson Disease Parkinsonian Disorders Pharyngeal Diseases Synucleinopathies

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northwestern University

Evanston, Illinois, 60208, United States

Location status: Recruiting

Location contact

Kate Davidson

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Percent agreement with Gold Standard

    Time frame: 1 year

    Percent agreement between experimental sensor Gold standard (GS) respiratory inductance plethysmography (RIP) with Inductotrace System®, Ambulatory Monitoring)

  2. Change in mean swallow frequency during haptic cueing week

    Time frame: Week 1 to Week 2

    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.

Secondary outcomes

  1. Change in algorithm-detected swallow frequency during haptic cueing week

    Time frame: Week 1 to Week 2

    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.

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

    Time frame: Baseline to Week 3

    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.

  3. Change in ROMP-Swallowing Subscale score

    Time frame: Baseline to Week 3

    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.

  4. Change in participant adherence to haptic cueing

    Time frame: Week 2

    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.

Other outcomes

  1. Change in Modified Barium Swallow Impairment Profile (MBSImP)

    Time frame: Baseline to Week 3

    Subsample of participants will undergo video fluoroscopy to evaluate swallowing function. The MBSImP scores will assess changes in swallow physiology pre- and post-intervention.

  2. Change in Penetration-Aspiration Scale Score

    Time frame: Baseline to Week 3

    Assesses airway protection during swallowing via penetration-aspiration scale scores from videofluoroscopic studies in a subsample of participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Ankita Bhutada

CONTACT

[email protected]

251-622-7112

Kate M Davidson

CONTACT

[email protected]

(803) 413-2435

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2020
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.