Refining Cough Skill Training in Parkinson's Disease and Dysphagia

NCT ID: NCT05700838

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2023-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease Dysphagia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cough Skill Training - with Variable Practice

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teachers College, Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Michelle Troche

Associate Professor, Lab Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Teachers College, Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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23-016

Identifier Type: -

Identifier Source: org_study_id

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