Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02927691
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
University of Florida
Information provided by (Responsible Party):
Teachers College, Columbia University

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Dysphagia Dystussia Device: EMST Behavioral: smTAP Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
Study Start Date : September 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Treatment
Participants will begin treatment immediately following baseline testing.
Device: EMST
Behavioral: smTAP
Delayed Treatment
Following baseline testing, participants will receive no treatment for five weeks, then begin treatment immediately following a second baseline testing session.
Device: EMST
Behavioral: smTAP



Primary Outcome Measures :
  1. Change in Penetration Aspiration Scale (PAS) Score [ Time Frame: Baseline(s) (Week 1 and potentially Week 7) and Post-treatment (Week 7 or Week 13) ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927691


Contacts
Layout table for location contacts
Contact: Michelle S Troche, PhD 212-678-3072 uadlab@tc.columbia.edu
Contact: Sarah Perry, PhD 212-678-3072 uadlab@tc.columbia.edu

Locations
Layout table for location information
United States, New York
Teachers College, Columbia University Recruiting
New York, New York, United States, 10027
Contact: Sarah Perry, PhD    212-678-3072    uadlab@tc.columbia.edu   
Contact: Avery Dakin, MA    212-678-3027    uadlab@tc.columbia.edu   
Sponsors and Collaborators
Teachers College, Columbia University
Michael J. Fox Foundation for Parkinson's Research
University of Florida
Layout table for additonal information
Responsible Party: Teachers College, Columbia University
ClinicalTrials.gov Identifier: NCT02927691    
Other Study ID Numbers: 542528
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: March 2020
Keywords provided by Teachers College, Columbia University:
Rehabilitation
Parkinson's disease
Swallowing
Cough
Dysphagia
Dystussia
Additional relevant MeSH terms:
Layout table for MeSH terms
Deglutition Disorders
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases