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RecruitingPhase 2

Rehabilitation of Airway Protection in Parkinson's Disease

Rehabilitation of Airway Protection in Parkinson's Disease: Comparing In-person and Telehealth Service Delivery Models

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares treatment given in person with treatment given through telehealth (remote visits). It is for people with Parkinson's disease who have trouble keeping liquids out of their airway or coughing strongly. Researchers will also study how treatment demands and following the treatment plan affect results.

Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 50 to 90 years old.
  • You have Parkinson's disease at stage II to IV, confirmed by a specialist using a recorded exam and set guidelines.
  • Swallowing tests show that thin liquids enter your airway, and/or cough tests show a weak cough.
  • You are not currently getting swallowing therapy that uses exercises.

Who can't join

  • You have another brain or nerve disorder, such as multiple sclerosis, a stroke, or a brain tumor.
  • You have had head or neck cancer.
  • You have a history of breathing disorders or lung disease, such as COPD.
  • You have smoked in the past five years.
  • You have high blood pressure that is not controlled.
  • Severe depression or dementia makes it hard to follow study instructions, based on set test scores.
  • You are allergic to capsaicin (the substance that makes peppers hot) or barium (used in some swallowing tests).
  • You live more than 1.5 hours door to door from either Teachers College, Columbia University, or Purdue University.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: * Diagnosed with PD (Hoehn and Yahr Stages II-IV)126,127 confirmed by a Movement Disorders fellowship trained neurologist having reviewed the video recorded Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessment for each participant and using strict UK brain bank criteria * airway protective deficits as defined as a minimum of penetration of thin liquids (penetration-aspiration score\>3) as determined by instrumental swallowing assessment and/or dystussia as determined by voluntary cough assessment (PEFR ≤4.1 L/s) * not actively receiving exercise-based swallowing therapy * between the ages of 50 and 90. Exclusion criteria: * Other neurological disorders (e.g., multiple sclerosis, stroke, brain tumor, etc.) * history of head and neck cancer * history of breathing disorders or diseases (e.g., COPD) * history of smoking in the last five years * uncontrolled hypertension * difficulty complying due to neuropsychological dysfunction (i.e., severe depression with \>28 on the Beck Depression Index (BDI-II), dementia with \<19 on the Montreal Cognitive Assessment (MoCA)) * allergy to capsaicin or barium * further than 1.5 hours (door to door) distance from either Teachers College, Columbia University or Purdue University.

Study sites (2)

IN

NY