Phase 2
N=65
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
Parkinson's Disease · Dysphagia · Dystussia
Bottom Line
View on ClinicalTrials.gov: NCT02927691 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Voluntary Cough Peak Flow — 0.17; 0.51 l/s
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EMST (Device); smTAP (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Teachers College, Columbia University
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Voluntary Cough Peak Flow |
0.17; 0.51 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02927691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.