RightFit
RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD."
  • "The project goal is the development and early stage validation of a wearable sensor for dysphagia in patients with PD."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is developing and doing early testing of a wearable sensor for swallowing problems. It is for adults with Parkinson's disease who have mild to moderate drooling.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 22 or older.
  • Speak English.
  • Have idiopathic Parkinson's disease, meaning its cause is unknown, diagnosed by a neurologist. Any stage is allowed.
  • Have mild to moderate drooling, with a score of 11 or higher on the ROMP-Saliva rating scale.
  • Be in the medication “on” phase during all study tests. This is when your medicine works best and helps you move most easily.

Who can't join

  • Had aspiration pneumonia in the past 12 months—a lung infection caused by food, liquid, or saliva entering the lungs.
  • Cannot swallow saliva without using a special swallowing technique, or are currently being treated for swallowing problems or drooling.
  • Currently abuse alcohol or drugs.
  • Have a brain or nerve disorder other than Parkinson's disease, or have end-stage dementia.
  • Have had head or neck cancer or surgery.
  • Cannot show that you can use the sensor system.
  • Have an allergy to the contrast material used in the swallowing X-ray test (MBSS) or to the sensor's sticky backing.
  • Have a breathing tube in your neck, have a feeding tube through your nose, or are currently pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

IL