RecruitingNot ApplicableNCT05708885

Striated Esophageal Motor Function Modulation in Health and Disease

Characterization of the Striated Esophagus (St.Eso) Deglutitive Motor Function and Its Modulation by Pharyngeal Phase Swallow Biomechanics

Sponsor

Medical College of Wisconsin

Enrollment

557 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

Dysphagia, Esophageal

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria2

Healthy subjects aged 18 to 90 years.
Patents with dysphagia but normal high resolution esophageal manometric findings defined by the Chicago classification.

Exclusion Criteria9

Anyone less than 18 years old.
Patients with recent head and neck cancer (<1 month post-surgery or <3 months post-chemo radiation.
Patients suffering from muscle diseases like muscular dystrophies, myopathies.
Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders.
Patients having history of allergy to lidocaine or barium.
Patients who are pregnant or lactating.
Patients who are medically unstable.
Patients who are unable to apply the exerciser independently or with the help of a caregiver.
Patients who lack cognition.

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Interventions

DEVICEConcurrent 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.

DEVICEConcurrent 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.