Skip to main content
Clinical Trials/NCT02927691
NCT02927691
Completed
Phase 2

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

Teachers College, Columbia University1 site in 1 country65 target enrollmentSeptember 2016

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Teachers College, Columbia University
Enrollment
65
Locations
1
Primary Endpoint
Change in Voluntary Cough Peak Flow
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
June 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials