Refining Cough Skill Training in Parkinson's Disease and Dysphagia

Parkinson Disease Clinical Trial

Official title:

Refining Cough Skill Training in Parkinson's Disease and Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05700838
• Other study ID #: 23-016
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: April 2024
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Parkinson Disease

Intervention

Behavioral:
• Cough Skill Training - with Variable Practice
Variable practice will involve three targets that reflect a range of cough airflows, including "strong", "moderate", and "weak" coughs.

Locations

Country	Name	City	State
United States	Teachers College, Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teachers College, Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Expiratory Flow Rate	Cough Strength	Before to after two sessions of cough variable practice training over two weeks
Secondary	Change in Respiratory Kinematics, specifically lung volume excursion		Before to after two sessions of cough variable practice training over two weeks