Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
NCT ID: NCT02927691
Last Updated: 2023-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2016-09-30
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediate Treatment
Participants will begin treatment immediately following baseline testing.
EMST
smTAP
Delayed Treatment
Following baseline testing, participants will receive no treatment for five weeks, then begin treatment immediately following a second baseline testing session.
EMST
smTAP
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EMST
smTAP
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Difficulty swallowing
3. Not actively receiving swallowing therapy.
Exclusion Criteria
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
45 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Michael J. Fox Foundation for Parkinson's Research
OTHER
University of Florida
OTHER
Teachers College, Columbia University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Teachers College, Columbia University
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Troche MS, Curtis JA, Sevitz JS, Dakin AE, Perry SE, Borders JC, Grande AA, Mou Y, Vanegas-Arroyave N, Hegland KW. Rehabilitating Cough Dysfunction in Parkinson's Disease: A Randomized Controlled Trial. Mov Disord. 2023 Feb;38(2):201-211. doi: 10.1002/mds.29268. Epub 2022 Nov 7.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
542528
Identifier Type: -
Identifier Source: org_study_id