Digital therapy for swallowing and drooling issues in Parkinson's
A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
This study is testing a new wearable sensor to help people with Parkinson's manage swallowing and drooling issues to improve their daily lives.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Evanston, Illinois) |
| Trial ID | NCT04664634 on ClinicalTrials.gov |
What this trial studies
This project focuses on developing and validating a wearable sensor designed to assist patients with dysphagia related to Parkinson's disease. The study is structured in three phases: first, enhancing the sensor's battery life and reducing its size; second, conducting focus groups with patients to gather feedback on usability; and third, testing the sensor's ability to detect and prompt swallowing in a small group of participants. The goal is to create a practical tool that can improve the quality of life for those affected by these symptoms.
Who should consider this trial
Good fit: Ideal candidates include English-speaking adults aged 22 and older with a diagnosis of idiopathic Parkinson's disease at any stage.
Not a fit: Patients with a history of aspiration pneumonia, severe swallowing difficulties, or other neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve swallowing function and reduce drooling in patients with Parkinson's disease.
How similar studies have performed: While there have been studies on digital therapeutics for various conditions, this specific approach using a wearable sensor for dysphagia in Parkinson's is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Evanston, Illinois
- Northwestern University — Evanston, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Ankita Bhutada
- Email: ankita.bhutada@northwestern.edu
- Phone: 251-622-7112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.