Swallowing Pressure Profiles in Healthy Adults

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: Videofluoroscopic swallow study; Procedure: pharyngeal High Resolution Manometry

• Registration Number: NCT03986554
• Lead Sponsor: University of Florida

Brief Summary

This study is designed to determine the impact of a pharyngeal High Resolution Manometry catheter on swallowing biomechanics

Detailed Description

During pharyngeal High Resolution Manometry (pHRM) a small bore flexible catheter is introduced into the pharynx to detect intrabolus pressure and contact of pharyngeal structures during swallowing. The presence of the catheter through the upper esophageal sphincter (UES) leads to a violation of its natural closed state. It is not clear how this intrusion influences the swallowing biomechanics . Hence, this project's goal is to identify how hyoid movement is altered during swallowing with the presence of a pHRM catheter in place.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-14
• Study Start: 2019-07-09
• Primary Completion: 2019-07-19
• Study Completion: 2019-07-19
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• healthy adults between the ages of 18-45 with no major medical conditions.
• no specific gender or race will be excluded or targeted for participation in this study.

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Exclusion Criteria

• adults who are pregnant
• adults with swallowing impairment, brain injury, deviated septum, G.I. strictures, obstructions, or Zenker's diverticulum, surgeries to nose, neck, or throat, or bleeding disorders will be excluded from this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Randomization Visit A	Videofluoroscopic swallow study	Participants enrolled in this arm will consume 300ml of water over 60 minutes. Each session will consist of 30 swallows broken into three 10-swallow sequences of 10ml of water. Each sequence will be use VFSS to visualize swallows.
Randomization Visit B	Videofluoroscopic swallow study	Participants enrolled in this arm will consume 300ml of water over 60 minutes. Each session will consist of 30 swallows broken into three 10-swallow sequences of 10ml of water. Sequences 1 and 3 will use videofluoroscopy only, while sequence 2 will use VFSS with simultaneous pharyngeal high resolution manometry in order to visualize swallows.
Randomization Visit B	pharyngeal High Resolution Manometry	Participants enrolled in this arm will consume 300ml of water over 60 minutes. Each session will consist of 30 swallows broken into three 10-swallow sequences of 10ml of water. Sequences 1 and 3 will use videofluoroscopy only, while sequence 2 will use VFSS with simultaneous pharyngeal high resolution manometry in order to visualize swallows.

Primary Outcome Measures

Name	Time	Method
Change in peak anterior and superior hyoid movement	Baseline; Week 1	peak hyoid movement (mm)

Trial Locations

Locations (1)

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States