Refining Cough Skill Training in Parkinson's Disease and Dysphagia

NCT05700838 | Completed Phase 1

• 1 other identifier: 23-016
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Change in Peak Expiratory Flow Rate

  Cough Strength

  Before to after two sessions of cough variable practice training over two weeks

Secondary Outcomes (1)

• Change in Respiratory Kinematics, specifically lung volume excursion

  Before to after two sessions of cough variable practice training over two weeks

Study Arms (1)

Cough Skill Training

EXPERIMENTAL

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

Interventions

Cough Skill Training - with Variable Practice BEHAVIORAL

Variable practice will involve three targets that reflect a range of cough airflows, including "strong", "moderate", and "weak" coughs.

Cough Skill Training

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Lab Director

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 26, 2023
• Study Start: September 21, 2022
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)