Cough According to Stimulus Type in PD

Summary

Aspiration pneumonia (APn) occurs at a higher rate in patients with Parkinson's disease (PD) versus healthy adults. This is of particular public health concern given that death secondary to aspiration pneumonia and lung infection is a leading cause of death in persons with PD. Swallowing and cough function are affected in PD, putting people with PD at significant risk for uncompensated aspiration (aspiration without adequate cough response). One challenge in the management of airway protective deficits related to PD is the chronic and progressive nature of the disease, where swallowing dysfunction appears subtly in the form of microaspiration, reducing the perceived urgency of the swallowing disorder by both clinicians and patients. The long-term goal of this research is to advance the management of airway protection deficits in patients with neurodegenerative disease in order to decrease morbidity and mortality due to aspiration related lung infection. The objective here is to further specify deficits leading to uncompensated airway compromise in PD in order to advance the clinical management of these patients, leading to an immediate positive impact.

Conditions

• Parkinson's Disease

Interventions

DRUG

Capsaicin vapor

Single-breath and continuous inhalation paradigm to induce cough.

OTHER

fog

Continuous inhalation of fog until a cough is produced, or up to 60 seconds (whichever is shortest)

RADIATION

Videofluoroscopic swallow evaluation

Fluoroscopic evaluation of oropharyngeal swallowing function.

DEVICE

Nebulizer

A hand-held nebulizer will be used to aerosolize the capsaicin and water solutions. Participants will inhale through the device's mouthpiece, and cough if they need to.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• Karen W Hegland, PHD · University of Florida

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2017-02-10

Completion

2019-02-13

FDA Drug

Yes

Countries

• United States

Study Locations