CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
Capsaicin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03321019
NCT03321019N/ACompleted
CompareCT.gov

Mechanisms of Airway Protection Dysfunction in Parkinson's Disease

University of Florida·observational·Posted Oct 25, 2017·Updated Oct 10, 2024

In Brief

An observational study evaluating Capsaicin, Resistive respiratory loads, and 2 other interventions for Parkinson Disease. Completed, enrolled 119 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 25, 2017
Enrollment StartDec 12, 2017
Primary CompletionJul 29, 2023
Study CompletionSep 29, 2023
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 8.7 years ago

Interventions

Capsaicindrug

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

Resistive respiratory loadsdevice

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.

Event-related evoked potential using electroencephalography (EEG).other

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

Fluoroscopic swallow evaluationprocedure

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