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Striated Esophageal Motor Function Modulation in Health and Disease

NCT05708885 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 557

Last updated 2026-05-05

No results posted yet for this study

Summary

The investigators hypothesize that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics.

Conditions

  • Dysphagia, Esophageal

Interventions

DEVICE

Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction

To reduce the laryngeal movement and St.Eso excursion we will use a device constructed in our laboratory which can induce an adjustable resistance to excursion of the larynx. This handmade device that is worn around the neck consists of a band and a concave plastic disk which serves as a support structure for an inflatable polyethylene bag which is connected to a hand pump and pressure gauge. When worn around the neck the inflatable bag rests in position on the thyroid cartilage with a portion of it hung over above the cartilage creating resistance to its superior excursion when fixed by closure straps. A known external force may be applied to the thyroid by partially inflating the bag to a specific pressure reading on the gauge. The soft and compliant bag conforms to the larynx while applying a resistive force to anterior and superior distraction of the hyolaryngeal complex during swallowing.

DEVICE

Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device

Use the previously mentioned wearable device (sRED) and exercise regimen described previously for studying the effect of increase in anterosuperior excursion of the larynx/St.Eso on St.Eso peristaltic function.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Reza Shaker · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05708885 on ClinicalTrials.gov