Aria Sensor for Parkinson's (NCT04664634)
Reduce drooling and improve swallowing
- Trial ID
- NCT04664634
- Official Title
- A Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's
- Goal
- Reduce drooling and improve swallowing
- Phase
- PHASE3
- Status
- RECRUITING
- Sponsor
- Northwestern University
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Dysphagia, Parkinson Disease
- Interventions
- Aria Sensor
Summary For Families
Aims to reduce drooling and improve swallowing safety and control for people with Parkinson's who have mild to moderate sialorrhea. It uses the Aria Sensor, a wearable digital therapeutic platform that senses swallowing and saliva events and delivers real-time feedback and guided exercises to help retrain swallowing and saliva management, working alongside your usual Parkinson's medications rather than replacing them. Assessments are done while you are in the "on" phase of your medication so results reflect your best motor function. Looking for English-speaking adults 22 and older with idiopathic Parkinson's at any Hoehn and Yahr stage, a ROMP-Saliva C score of 11 or higher, ability to use the sensor, and no recent aspiration pneumonia, active drooling treatments, feeding tubes, or certain allergies.
Locations
- Northwestern University, Evanston, Illinois, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Aria Sensor. Aims to reduce drooling and improve swallowing safety and control for people with Parkinson's who have mild to moderate sialorrhea. It uses the Aria Sensor, a wearable digital therapeutic platform that senses swallowing and saliva events and delivers real-time feedback and guided exercises to help retrain swallowing and saliva management, working alongside your usual Parkinson's medications rather than replacing them. Assessments are done while you are in the "on" phase of your medication so results reflect your best motor function. Looking for English-speaking adults 22 and older with idiopathic Parkinson's at any Hoehn and Yahr stage, a ROMP-Saliva C score of 11 or higher, ability to use the sensor, and no recent aspiration pneumonia, active drooling treatments, feeding tubes, or certain allergies.
- Who can participate?
- Participants must be at least 22 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 1 year and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.