NCT04773184

Improving Diagnostic Standards in Dysphagia

Improving Clinical and Instrumental Diagnostic Standards in Dysphagia.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to understand the normal function of swallowing and respiratory muscles in order to establish normal parameters. This will allow us to compare normal physiology and function of swallowing and breathing muscles to people with a medical history that would put them at risk for a swallowing problem. Our goal is to identify the best tests that can be quickly and easily administered to accurately detect swallowing impairment in adults. Involvement is limited to a single 2-hour evaluation.

Detailed description

The purpose of this research is to understand the normal function of swallowing and respiratory muscles in order to establish normal parameters. It will take approximately 90-120 minutes to complete. During this examination, you will have respiratory testing, cough testing, lingual testing, voice testing, and will be asked to fill out some surveys. We will then complete the swallowing test that uses both a moving x-ray and a small camera will be inserted into the open passage of your nose to the back of your throat to watch your swallow and look at your vocal folds (voice box). This will allow us to compare normal physiology and function of swallowing and breathing muscles to people with a medical history that would put them at risk for a swallowing problem. Our goal is to identify the best tests that can be quickly and easily administered to accurately detect swallowing impairment in adults. Your involvement is limited to a single 2-hour evaluation.

Conditions

• Dysphagia

Interventions

Type	Name	Description
PROCEDURE	Fiberoptic Endoscopic Evaluation of Swallowing	This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
PROCEDURE	Videofluoroscopic Swallowing Study	Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing. This is like a moving x-ray of the swallow.
PROCEDURE	Voluntary Peak Cough Flow Testing	Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.
PROCEDURE	Iowa Oral Performance Instrument	The Iowa Oral Performance Instrument (IOPI) is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
PROCEDURE	Capsaicin Challenge	A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds.
PROCEDURE	Pulmonary Function Testing	Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) expressed as a percentage of predicted values.
OTHER	Voicing Tasks	Voicing tasks will be completed to assess vocal ability.

Timeline

• Start date: 2021-04-27
• Primary completion: 2023-09-23
• Completion: 2023-09-23
• First posted: 2021-02-26
• Last updated: 2024-01-17

Locations

1 site across 1 country: United States