Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
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|ClinicalTrials.gov Identifier: NCT02927691|
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Dysphagia Dystussia||Device: EMST Behavioral: smTAP||Phase 2|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Immediate Treatment
Participants will begin treatment immediately following baseline testing.
Following baseline testing, participants will receive no treatment for five weeks, then begin treatment immediately following a second baseline testing session.
- Change in Penetration Aspiration Scale (PAS) Score [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927691
|Contact: Michelle S Troche, PhDfirstname.lastname@example.org|
|Contact: Sarah Perry, PhDemail@example.com|