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Airway Protective Mechanisms in PD (R01)

NCT03321019 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 119

Last updated 2024-10-10

Study results available
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Summary

This study will collect data on various aspects of airway sensation and function, and determine how it relates to the development of swallowing and cough dysfunction in Parkinson's disease. Participants will be followed over a 3-year period, with once-per-year visits to collect the data.

Conditions

  • Parkinson Disease

Interventions

DRUG

Capsaicin

Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.

DEVICE

Resistive respiratory loads

Participants will breath through a mouthpiece. Every 3-5 breaths in, a respiratory load will be applied. Participants will be asked to rate the magnitude of the load.

OTHER

Event-related evoked potential using electroencephalography (EEG).

The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.

PROCEDURE

Fluoroscopic swallow evaluation

Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Karen Hegland, PhD · University of Florida

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2023-07-29
Completion
2023-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03321019 on ClinicalTrials.gov