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

Teachers College, Columbia University

Status and phase: Completed; Phase 2

Conditions: Dystussia; Dysphagia; Parkinson's Disease

Treatments: Behavioral: smTAP; Device: EMST

Study type: Interventional

Funder types: Other

Identifiers

NCT02927691

542528

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Immediate Treatment

Experimental group

Description:

Participants will begin treatment immediately following baseline testing.

Treatment:

Device: EMST

Behavioral: smTAP

Delayed Treatment

Other group

Description:

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

Treatment:

Device: EMST

Behavioral: smTAP