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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 1 year and 2 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.