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Swallowing Pressure Profiles in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03986554
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This study is designed to determine the impact of the pharyngeal High Resolution Manometry catheter on swallowing biomechanics in order to identify how feedforward adaptation occurs in pharyngeal function. This information can potentially assist clinicians with targeted interventions to treat dysphagia.

Condition or disease Intervention/treatment Phase
Healthy Procedure: Videofluoroscopic swallow study Procedure: pharyngeal High Resolution Manometry Not Applicable

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 responsible for the opening of the UES. Hence, this project's goal is to identify how swallowing biomechanics related to pharyngeal function, specifically hyolaryngeal elevation and pharyngeal shortening, change or adapt in the presence of the catheter using videofluoroscopic swallowing study (VFSS). The results of this study will provide novel information concerning the impact of the pHRM catheter in swallowing and explore the role pharyngeal adaptation plays in the regulation of feedforward mechanisms of the UES opening.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will include healthy adults, between the ages of 18 and 45 years with no major medical history.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Swallowing Pressure Profiles in Healthy Adults
Actual Study Start Date : July 9, 2019
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : July 19, 2019

Arm Intervention/treatment
Randomization Visit A
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.
Procedure: Videofluoroscopic swallow study
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 Name: VFSS, x-ray of swallowing

Randomization Visit B
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.
Procedure: Videofluoroscopic swallow study
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 Name: VFSS, x-ray of swallowing

Procedure: pharyngeal High Resolution Manometry
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 Name: pHRM, HRM




Primary Outcome Measures :
  1. Change in swallow timing / temporal kinematics associated with hyolaryngeal elevation [ Time Frame: Baseline; Week 1 ]
    Changes in duration of laryngeal vestibule closure (dLVC), duration to laryngeal vestibule closure (dtLVC), and duration to maximum hyoid bone elevation (dtHME) in miliseconds will be measured.

  2. Change in hyoid kinematics associated with hyolaryngeal elevation events. [ Time Frame: Baseline; Week 1 ]
    The maximum value of anterior and superior displacement of the hyoid (in normalized units of distance relative to C2-C4 reference scalar) will be measured at rest and during swallowing.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986554


Locations
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United States, Florida
UF Health at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Emily K Plowman, PhD University of Florida

Publications:
Omari, T. et al .The Utility of High-Resolution Pharyngeal Manometry in Dysphagia Treatment | Perspectives of the ASHA Special Interest Groups. Available at: https://pubs.asha.org/doi/full/10.1044/2019_PERS-SIG13-2018-0027. (Accessed: 7th June 2019)

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03986554     History of Changes
Other Study ID Numbers: IRB201901651
OCR24403 ( Other Identifier: UF OnCore )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Swallowing