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Completed

NCT Number: NCT02927691

Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial

Currently, there are no efficacious behavioral treatment approaches to address uncompensated aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD). This is of particular public health concern given that aspiration pneumonia is the leading cause of death in persons with PD. The overarching aim of the proposed study is to determine the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate the results will lead to reductions in the risks associated with airway protective deficits.

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Key information

About this study

Study Rationale:

Aspiration pneumonia is a leading cause of death in persons with Parkinson's disease (PD). One of the main reasons people with PD develop aspiration pneumonia is that they often have both swallowing dysfunction (dysphagia) and cough dysfunction (dystussia). Because of this, if food or liquid enters the airway, a cough is not elicited and the material remains in the airway (silent aspiration). It is then possible for the material to enter the lungs resulting in an infection called aspiration pneumonia. Currently, there are no tested treatment approaches that specifically target silent aspiration.

Hypothesis:

The goal of this study is to determine how well two different rehabilitation treatments, expiratory muscle strength training (EMST) and sensorimotor treatment for airway protection (smTAP), work to improve cough and swallowing function in persons with PD and dysphagia.

Study Design:

This study will include two participant groups; one group will receive EMST and the other will receive smTAP. There will be initial baseline testing of swallowing, coughing, respiratory, and laryngeal function. The investigators will also measure the participants' perception of their cough and swallowing problem. Then, participants will be randomly assigned (much like the flip of a coin) to either the EMST or smTAP training groups. The participants will be further randomized to receive immediate training or delayed training where there is a 5-week wait to start with a second baseline performed at the end of the 5-week delay. Once training is complete the participants will once again complete measures of swallowing, coughing, respiratory and laryngeal function.

Impact on Diagnosis/Treatment of Parkinson's Disease:

The investigators anticipate that this study will assist in better understanding what treatments work best to improve swallowing and cough in people with PD; resulting in an immediate shift in the clinical management of swallowing and cough dysfunction in PD. The investigators also believe that participants will have improvements in swallowing and cough function; therefore, reducing the risk of aspiration pneumonia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with PD (Hoehn and Yahr Stages II-IV)
  • Difficulty swallowing
  • Not actively receiving swallowing therapy.

Exclusion criteria

  • Other neurological disorders (e.g., multiple sclerosis, stroke, etc.)
  • History of head and neck cancer
  • History of breathing disorders or diseases (e.g., COPD)
  • History of smoking in the last five years
  • Uncontrolled hypertension
  • Difficulty complying due to neuropsychological dysfunction

Treatment and study plan

EMST

Device

smTAP

Behavioral

Primary outcomes

  1. Change in Voluntary Cough Peak Flow

    Time frame: Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks)

    Peak expiratory flow rate (PEFR) was measured before (baseline) and after 5 weeks of treatment with EMST and smTAP.

Sponsors and collaborators

Lead sponsor

Teachers College, Columbia University

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research
  • University of Florida

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 7, 2016
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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