RECRUITING Phase 2 ClinicalTrials.gov

Rehabilitation of Airway Protection in Parkinson's Disease

Sponsor: Teachers College, Columbia University • ClinicalTrials.gov ID: NCT05700825

Registry updated: 2026-10-08

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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. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.

Interventions

Expiratory Muscle Strength Training + Cough Skill Training (Behavioral)
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.

Eligibility criteria

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 (i.e., severe depression with \>28 on the Beck Depression Index (BDI-II), dementia with \<19 on the Montreal Cognitive Assessment (MoCA)) * allergy to capsaicin or barium * further than 1.5 hours (door to door) distance from either Teachers College, Columbia University or Purdue University.

Conditions

Parkinson Disease Dysphagia

Locations

Purdue University — West Lafayette, Indiana, United States
Teachers College, Columbia University — New York, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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