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



Status:Recruiting
Conditions:Parkinsons Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Neurology
Healthy:No
Age Range:45 - 85
Updated:9/19/2018
Start Date:September 2016
End Date:June 2019
Contact:Michelle S Troche, PhD
Email:uadlab@tc.columbia.edu
Phone:212-678-3072

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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.

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.

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
We found this trial at
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Phone: 212-678-3072
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