Refining Cough Skill Training in Parkinson's Disease and Dysphagia

Airway protection deficits (cough and swallowing) are prevalent and pervasive in Parkinson's disease (PD), contributing to adverse health outcomes like pneumonia. This study aims to refine cough skill training by examining whether variable versus constant practice conditions improve cough outcomes in people with PD. In addition, this study will provide insight into optimal respiratory adaptations that occur during training to support cough effectiveness, resulting in immediately translatable treatments to improve airway protection-related health outcomes in people with neurodegenerative disease.

Completed

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Otorhinolaryngologic Diseases Parkinsonian Disorders Pharyngeal Diseases Synucleinopathies

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Teachers College, Columbia University

New York, 10027, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

40 years of age or older
have dysphagia as documented by a penetration-aspiration score > 2 on a flexible endoscopic evaluation of swallowing
have cough disorder as defined as a maximal voluntary cough peak flow < 5 L/s
have no history of other neurological disorders, head and neck cancer, respiratory disease, smoking within 5 years, uncontrolled hypertension, or allergy to capsaicin (reflex cough stimulus)

Exclusion criteria

unable to participate due to neuropsychological dysfunction (i.e., dementia with a score of < 19 on the Montreal Cognitive Assessment)
actively participating in other cough or swallowing treatments

Treatment and study plan

Cough Skill Training - with Variable Practice

Behavioral

Variable practice will involve three targets that reflect a range of cough airflows, including "strong", "moderate", and "weak" coughs.

Primary outcomes

Change in Peak Expiratory Flow Rate

Time frame: Before to after two sessions of cough variable practice training over two weeks

Cough Strength

Secondary outcomes

Change in Respiratory Kinematics, specifically lung volume excursion

Time frame: Before to after two sessions of cough variable practice training over two weeks

Sponsors and collaborators

Lead sponsor

Teachers College, Columbia University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jan 26, 2023
Registry last updated: Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed