Swallowing Pressure Profiles in Healthy Adults

NCT03986554 | Completed

• 2 other identifiers: IRB201901651OCR24403
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Swallowing

Outcome Measures

Primary Outcomes (1)

• Change in peak anterior and superior hyoid movement

  peak hyoid movement (mm)

  Baseline; Week 1

Study Arms (2)

Randomization Visit A

OTHER

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

Randomization Visit B

OTHER

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; Procedure: pharyngeal High Resolution Manometry

Interventions

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.

Also known as: VFSS, x-ray of swallowing

Randomization Visit A; Randomization Visit B

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.

Also known as: pHRM, HRM

Randomization Visit B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Study Officials

• Emily K Plowman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will include healthy adults, between the ages of 18 and 45 years with no major medical history.

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 14, 2019
• Study Start: July 9, 2019
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)