Skip to main content
OpenTrials
Completed

NCT Number: NCT03986554

Swallowing Pressure Profiles in Healthy Adults

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Videofluoroscopic Swallow Study

Procedure

The Swallowing Systems Core laboratory is fully equipped to perform VFSS with a C-arm (OEC 9900) that is dedicated solely for research purposes. VFSS recordings will be kept to a minimum and only turned on during the execution of each swallow in all sequences. Video recording and images captured during the VFSS will be synced and saved to a secure server for data analysis. VFSS allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks. The physiological swallowing measures (temporal and kinematic movement of the hyolaryngeal complex during swallowing) cannot be visualized with any other technique. Patients will swallow only water. Aspiration (bolus into trachea) is not expected to occur during this study given that the individuals recruited will have no prior history of disease or disorder, and aspiration is uncommon in healthy individuals.

Other names: VFSS, x-ray of swallowing

pharyngeal High Resolution Manometry

Procedure

This procedure will only take place once during sequence 2 of the randomization B session. If desired, a small amount (< 0.5 mL) of topical 2% viscous lidocaine hydrochloride will be applied to the participant's nostril of choice prior to catheter insertion. The catheter will be placed through the nasal passage, oropharynx, and hypopharynx to the esophagus. Correct catheter placement will be verified with VFSS. With the catheter in place, the subject will perform 10 swallows of 10ml and is expected to take approximately 2.5 minutes. The catheter will then be removed and the subject will move on to sequence 3. Individuals have the option to decline this procedure if it is uncomfortable or difficult to tolerate.

Other names: pHRM, HRM

Primary outcomes

  1. Change in peak anterior and superior hyoid movement

    Time frame: Baseline; Week 1

    peak hyoid movement (mm)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2019
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.