NCT05700825 · Teachers College, Columbia University
Rehabilitation of Airway Protection in Parkinson's Disease
What this study is about
Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits.
View original scientific description
Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits.
Interventions
BEHAVIORAL
Expiratory Muscle Strength Training + Cough Skill Training
Expiratory Muscle Strength Training (EMST). EMST is a widely used and efficacious treatment approach that uses a calibrated device with a one-way, spring-loaded pressure relief valve to mechanically overload the expiratory and submental muscles. Cough Skill Training (CST) involves a digital peak flow meter device which measures PEFR (peak expiratory flow rate) in liters/second and allows patients to receive immediate biofeedback.
Primary outcome measures
Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 1
Time frame: Pretraining to posttraining (after four weeks of intensive training)
Change in Peak Expiratory Flow Rate (Cough PEFR) - phase 2
Time frame: post-training to post one-year maintenance
Change in Penetration-Aspiration Scale (PAS) - phase 1
Time frame: Pretraining to posttraining (after four weeks of intensive training)
PAS, max value: 8 (most impaired), min value 1 (least impaired).
Change in Penetration-Aspiration Scale (PAS) - phase 2
Time frame: post-training to post one-year maintenance
PAS, max value: 8 (most impaired), min value 1 (least impaired).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosed with PD (Hoehn and Yahr Stages II-IV)126,127 confirmed by a Movement Disorders fellowship trained neurologist having reviewed the video recorded Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessment for each participant and using strict UK brain bank criteria
- airway protective deficits as defined as a minimum of penetration of thin liquids (penetration-aspiration score\>3) as determined by instrumental swallowing assessment and/or dystussia as determined by voluntary cough assessment (PEFR ≤4.1 L/s)
- not actively receiving exercise-based swallowing therapy
- between the ages of 50 and 90.
Exclusion criteria
- Other neurological disorders (e.g., multiple sclerosis, stroke, brain tumor, etc.)
- history of head and neck cancer
- history of breathing disorders or diseases (e.g., COPD)
- history of smoking in the last five years
- uncontrolled hypertension
- difficulty complying due to neuropsychological dysfunction
Where
- West Lafayette, Indiana
- New York, New York
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Purdue University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2025 · Source of record for eligibility and locations