Back to resultsRefining Cough Skill Training in Parkinson's Disease and Dysphagia
Primary Purpose
Parkinson Disease, Dysphagia
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cough Skill Training - with Variable Practice
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Teachers College, Columbia UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cough Skill Training
Arm Description
During cough skill training, participants will be seated in front of a computer with real-time visualization of their cough waveform. A target line will be provided, and participants will be instructed to perform a single voluntary cough so that their peak flow is within the target's range. Participants will be instructed to continue the cough training regardless of initial accuracy.
Outcomes
Primary Outcome Measures
Change in Peak Expiratory Flow Rate
Cough Strength
Secondary Outcome Measures
Change in Respiratory Kinematics, specifically lung volume excursion
Full Information
NCT ID
NCT05700838
First Posted
December 21, 2022
Last Updated
January 17, 2023
Sponsor
Teachers College, Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT05700838
Brief Title
Refining Cough Skill Training in Parkinson's Disease and Dysphagia
Official Title
Refining Cough Skill Training in Parkinson's Disease and Dysphagia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
May 21, 2025 (Anticipated)
Study Completion Date
May 21, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Teachers College, Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dysphagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cough Skill Training
Arm Type
Experimental
Arm Description
During cough skill training, participants will be seated in front of a computer with real-time visualization of their cough waveform. A target line will be provided, and participants will be instructed to perform a single voluntary cough so that their peak flow is within the target's range. Participants will be instructed to continue the cough training regardless of initial accuracy.
Intervention Type
Behavioral
Intervention Name(s)
Cough Skill Training - with Variable Practice
Intervention Description
Variable practice will involve three targets that reflect a range of cough airflows, including "strong", "moderate", and "weak" coughs.
Primary Outcome Measure Information:
Title
Change in Peak Expiratory Flow Rate
Description
Cough Strength
Time Frame
Before to after two sessions of cough variable practice training over two weeks
Secondary Outcome Measure Information:
Title
Change in Respiratory Kinematics, specifically lung volume excursion
Time Frame
Before to after two sessions of cough variable practice training over two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Borders, MS
Phone
212-678-3072
Email
jcb2271@tc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Troche, PhD
Phone
212-678-3072
Email
mst2139@tc.columbia.edu
Facility Information:
Facility Name
Teachers College, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Borders, MS
Phone
212-678-3072
Email
jcb2271@tc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Michelle Troche, PhD
Phone
212-678-3072
Email
mst2139@tc.columbia.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Refining Cough Skill Training in Parkinson's Disease and Dysphagia
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