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

Sponsor

Teachers College, Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT02927691

Collaborator

Michael J. Fox Foundation for Parkinson's Research (Other), University of Florida (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate Treatment Participants will begin treatment immediately following baseline testing.	Device: EMST Behavioral: smTAP
Other: 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

Arm

Intervention/Treatment

Experimental: Immediate Treatment

Participants will begin treatment immediately following baseline testing.

Device: EMST

Behavioral: smTAP

Other: 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

Outcome Measures

Primary Outcome Measures

Change in Penetration Aspiration Scale (PAS) Score [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)