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Clinical Trials/NCT05700838
NCT05700838CompletedPhase 1

Refining Cough Skill Training in Parkinson's Disease and Dysphagia

Teachers College, Columbia University1 site in 1 country23 target enrollmentStarted: September 21, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
23
Locations
1
Primary Endpoint
Change in Peak Expiratory Flow Rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Cough Skill Training - with Variable Practice (Behavioral)

Outcomes

Primary Outcomes

Change in Peak Expiratory Flow Rate

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

Cough Strength

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michelle Troche

Associate Professor, Lab Director

Teachers College, Columbia University

Study Sites (1)

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