Refining Cough Skill Training in Parkinson's Disease and Dysphagia

April 9, 2024 updated by: Michelle Troche, Teachers College, Columbia University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10027
        • Teachers College, Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cough Skill Training
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peak Expiratory Flow Rate
Time Frame: Before to after two sessions of cough variable practice training over two weeks
Cough Strength
Before to after two sessions of cough variable practice training over two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Respiratory Kinematics, specifically lung volume excursion
Time Frame: Before to after two sessions of cough variable practice training over two weeks
Before to after two sessions of cough variable practice training over two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teachers College, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe