Strengthen cough to reduce aspiration
- Trial ID
- NCT05700825
- Official Title
- Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-person and Telehealth Service Delivery Models
- Goal
- Strengthen cough to reduce aspiration
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Teachers College, Columbia University
- Study Type
- INTERVENTIONAL
- Enrollment
- 120 participants
- Conditions
- Parkinson Disease, Dysphagia
- Interventions
- Expiratory Muscle Strength Training + Cough Skill Training
Summary For Families
The goal is to improve airway protection so people with Parkinson's swallow more safely and have fewer episodes of choking or food and liquids entering the lungs. The program uses expiratory muscle strength training to strengthen the muscles you use to breathe out so you can generate a stronger, more effective cough, plus cough skill training to teach timing and technique, and it is being tested both in person and via telehealth to see if remote delivery works as well. This is a behavioral exercise program, not a drug, so it does not interact with levodopa or other Parkinson's medications. They are enrolling people ages 50 to 90 with Parkinson's at Hoehn and Yahr stages II to IV who show airway protection problems on instrumental swallowing tests or a weak voluntary cough, are not currently doing exercise-based swallowing therapy, and who do not have other neurologic, serious respiratory, recent smoking, uncontrolled hypertension, or severe cognitive or psychiatric issues.
Locations
- Purdue University, West Lafayette, Indiana, United States
- Teachers College, Columbia University, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Expiratory Muscle Strength Training + Cough Skill Training. The goal is to improve airway protection so people with Parkinson's swallow more safely and have fewer episodes of choking or food and liquids entering the lungs. The program uses expiratory muscle strength training to strengthen the muscles you use to breathe out so you can generate a stronger, more effective cough, plus cough skill training to teach timing and technique, and it is being tested both in person and via telehealth to see if remote delivery works as well. This is a behavioral exercise program, not a drug, so it does not interact with levodopa or other Parkinson's medications. They are enrolling people ages 50 to 90 with Parkinson's at Hoehn and Yahr stages II to IV who show airway protection problems on instrumental swallowing tests or a weak voluntary cough, are not currently doing exercise-based swallowing therapy, and who do not have other neurologic, serious respiratory, recent smoking, uncontrolled hypertension, or severe cognitive or psychiatric issues.
- Who can participate?
- Participants must be between 50 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 2 trial is estimated to last approximately 5 years and 1 month.
- 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.