Recruiting · registry status

Developing a wearable tool for swallowing and drooling problems

Researchers are developing and testing a wearable sensor and digital system to support swallowing care in Parkinson’s.

Testing a treatment or activity · Study reference: NCT04664634

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Looking for volunteers

Start (reported actual date): 2025-04-01
Main measurements finished (planned): 2026-10-31
Study finished (planned): 2026-10-31

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age 22 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.

Full study name & original research details

Official study title

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

Original description

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

Further description from the registry

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 reported: Dysphagia; Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

ClinicalTrials.gov · NCT04664634 ↗ — RECRUITING; checked 2026-10-11
ClinicalTrials.gov · NCT04664634 ↗ — Recruiting; WHO ICTRP processed 2026-08-31; checked 2026-10-11

Study type: Interventional
Interventions: Aria Sensor
Phases: PHASE3
Sponsor: Northwestern University
Start date reported by registry: 2025-04-01 (actual)

Registry updated: 2026-08-24 · Status last verified by the registry submitter: 2026-08

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Ankita Bhutada · 251-622-7112 · ankita.bhutada@northwestern.edu

Kate M Davidson · (803) 413-2435 · kate.humphries@northwestern.edu

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Northwestern University

Evanston, Illinois, United States

Recruiting

Kate Davidson

Facility not reported

United States

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.