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Airway Protection Rehabilitation for Parkinson's Disease
Phase 2
Recruiting
Led By Michelle Troche, PhD
Research Sponsored by Teachers College, Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-training to post one-year maintenance
Awards & highlights
No Placebo-Only Group
Summary
This trial will look at a novel treatment to improve airway protection in Parkinson’s Disease, which is the leading cause of death in PD. It will look at if this treatment works better in person or via telehealth and how patient burden and adherence affect outcomes.
Who is the study for?
This trial is for people aged 50-90 with Parkinson's Disease who have trouble swallowing or coughing but aren't currently getting therapy for it. They must be diagnosed by a specialist and can't have other neurological disorders, recent smoking history, breathing diseases, severe depression or dementia.
What is being tested?
The study tests whether training to strengthen the muscles used in breathing out and coughing helps protect the airway better than usual care. It compares results of doing these exercises in-person versus via telehealth to see which is more effective.
What are the potential side effects?
Potential side effects may include discomfort from exercising the expiratory muscles and possible irritation from capsaicin if used during assessments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-training to post one-year maintenance
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-training to post one-year maintenance
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Penetration-Aspiration Scale (PAS) - phase 1
Change in Penetration-Aspiration Scale (PAS) - phase 2
Secondary study objectives
Change in SWAL-QOL - phase 2
Change in SWAL-QOL- phase 1
Change in Treatment Adherence- phase 2
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TelehealthExperimental Treatment1 Intervention
Group II: In-personActive Control1 Intervention
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
652,072 Total Patients Enrolled
Teachers College, Columbia UniversityLead Sponsor
26 Previous Clinical Trials
5,919 Total Patients Enrolled
Purdue UniversityOTHER
233 Previous Clinical Trials
71,258 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had head or neck cancer in the past.My blood pressure is not well-controlled.I have trouble swallowing thin liquids or coughing effectively.I have Parkinson's disease, stages II-IV, confirmed by a specialist.I have a history of lung problems like COPD.I have a neurological disorder like MS, stroke, or brain tumor.I am not currently undergoing any exercise-based therapy for swallowing.I am between 50 and 90 years old.
Research Study Groups:
This trial has the following groups:- Group 1: In-person
- Group 2: Telehealth
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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