Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
Condition: Parkinson's Disease; Dysphagia; Dystussia
MeSH terms: Deglutition Disorders; Parkinson Disease
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): EMST; smTAP
Intervention type(s): Device; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Parkinson's disease; Swallowing; Cough; Dysphagia; Dystussia