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

Primary Purpose

Parkinson's Disease, Dysphagia, Dystussia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EMST
smTAP
Sponsored by
Teachers College, Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Rehabilitation, Parkinson's disease, Swallowing, Cough, Dysphagia, Dystussia

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Teachers College, Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate Treatment

Delayed Treatment

Arm Description

Participants will begin treatment immediately following baseline testing.

Following baseline testing, participants will receive no treatment for five weeks, then begin treatment immediately following a second baseline testing session.

Outcomes

Primary Outcome Measures

Change in Penetration Aspiration Scale (PAS) Score
If the participant is in the immediate treatment group: the PAS will be assessed at baseline (week 1) and then following the completion of five weeks of treatment (week 7) If the participant is in the delayed treatment arm: the PAS will be assessed at baseline (week 1), a second baseline will be completed at week 7, and then following the completion of five weeks of treatment the measures will be repeated again (week 13)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2016
Last Updated
December 14, 2021
Sponsor
Teachers College, Columbia University
Collaborators
Michael J. Fox Foundation for Parkinson's Research, University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02927691
Brief Title
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
Official Title
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teachers College, Columbia University
Collaborators
Michael J. Fox Foundation for Parkinson's Research, University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Dysphagia, Dystussia
Keywords
Rehabilitation, Parkinson's disease, Swallowing, Cough, Dysphagia, Dystussia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
Participants will begin treatment immediately following baseline testing.
Arm Title
Delayed Treatment
Arm Type
Other
Arm Description
Following baseline testing, participants will receive no treatment for five weeks, then begin treatment immediately following a second baseline testing session.
Intervention Type
Device
Intervention Name(s)
EMST
Intervention Type
Behavioral
Intervention Name(s)
smTAP
Primary Outcome Measure Information:
Title
Change in Penetration Aspiration Scale (PAS) Score
Description
If the participant is in the immediate treatment group: the PAS will be assessed at baseline (week 1) and then following the completion of five weeks of treatment (week 7) If the participant is in the delayed treatment arm: the PAS will be assessed at baseline (week 1), a second baseline will be completed at week 7, and then following the completion of five weeks of treatment the measures will be repeated again (week 13)
Time Frame
Baseline(s) (Week 1 and potentially Week 7) and Post-treatment (Week 7 or Week 13)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Teachers College, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States

12. IPD Sharing Statement

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

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