Refining Cough Skill Training in Parkinson's Disease and Dysphagia

Sponsor

Teachers College, Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05700838

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Dysphagia	Behavioral: Cough Skill Training - with Variable Practice	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Refining Cough Skill Training in Parkinson's Disease and Dysphagia

Actual Study Start Date :

Sep 21, 2022

Anticipated Primary Completion Date :

May 21, 2025

Anticipated Study Completion Date :

May 21, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Peak Expiratory Flow Rate [Before to after two sessions of cough variable practice training over two weeks]
Cough Strength

Secondary Outcome Measures

Change in Respiratory Kinematics, specifically lung volume excursion [Before to after two sessions of cough variable practice training over two weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teachers College, Columbia University	New York	New York	United States	10027

Sponsors and Collaborators

Teachers College, Columbia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michelle Troche, Associate Professor, Lab Director, Teachers College, Columbia University

ClinicalTrials.gov Identifier:

NCT05700838

Other Study ID Numbers:

23-016

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Deglutition Disorders

Parkinson Disease

Study Results

No Results Posted as of Jan 26, 2023