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Swallowing Pressure Profiles in Healthy Adults

Swallowing Pressure Profiles in Healthy Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03986554
Enrollment
10
Registered
2019-06-14
Start date
2019-07-09
Completion date
2019-07-19
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Swallowing

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.

Interventions

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.

PROCEDUREpharyngeal 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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in peak anterior and superior hyoid movementBaseline; Week 1peak hyoid movement (mm)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026