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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05700838
Other study ID # 23-016
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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