Striated Esophageal Motor Function Modulation in Health and Disease

NCT05708885 | Recruiting DMC FDA Device

• 1 other identifier: PRO00042719
• Study Type: interventional
• Target: 557
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysphagia, Esophageal

Outcome Measures

Primary Outcomes (12)

• peak deglutitive pharyngeal peristaltic wave pressure

  Peak deglutitive pharyngeal peristaltic wave pressure will be measured at positions 2-8cm above the upper margin of the manometrically determined upper esophageal sphincter high-pressure zone (UESHPZ)

  Before six weeks exerciser regimen, during deglutitive restriction of the larynx

• peak deglutitive pharyngeal peristaltic wave pressure

  Peak deglutitive pharyngeal peristaltic wave pressure will be measured at positions 2-8cm above the upper margin of the manometrically determined upper esophageal sphincter high-pressure zone (UESHPZ)

  After six weeks exerciser regimen, during deglutitive restriction of the larynx

• hypopharyngeal intra-bolus

  pressure within the swallowed bolus as it passes through the hypopharynx

  Before exerciser regimen, during deglutitive restriction of the larynx

• hypopharyngeal intra-bolus

  pressure within the swallowed bolus as it passes through the hypopharynx

  After exerciser regimen, during deglutitive restriction of the larynx

• upper esophageal sphincter (UES) nadir pressure

  minimum pressure during deglutitive UES relaxation

  Before six weeks exerciser regimen, during deglutitive restriction of the larynx

• upper esophageal sphincter (UES) nadir pressure

  minimum pressure during deglutitive UES relaxation

  After six weeks exerciser regimen, during deglutitive restriction of the larynx

• pharyngeal contractile integral

  Time-space integral of the pharynx during swallows as measured from the manometric display

  Before six weeks exerciser regimen, during deglutitive restriction of the larynx

• pharyngeal contractile integral

  Time-space integral of the pharynx during swallows as measured from the manometric display

  After six weeks exerciser regimen, during deglutitive restriction of the larynx

• maximum excursion of the hyo-laryngeal complex

  maximum deglutitive excursion of the hyoid and larynx from the pre-swallow resting position as measured from fluoroscopic images

  Before six weeks exerciser regimen, during deglutitive restriction of the larynx

• maximum excursion of the hyo-laryngeal complex

  maximum deglutitive excursion of the hyoid and larynx from the pre-swallow resting position as measured from fluoroscopic images

  After six weeks exerciser regimen, during deglutitive restriction of the larynx

• UES anterior-posterior maximum diameter during swallows

  maximum deglutitive diameter in the anterior-posterior direction of the UES measured from fluoroscopic images

  Before six weeks exerciser regimen, during deglutitive restriction of the larynx

• UES anterior-posterior maximum diameter during swallows

  maximum deglutitive diameter in the anterior-posterior direction of the UES measured from fluoroscopic images

  After six weeks exerciser regimen, during deglutitive restriction of the larynx

Study Arms (3)

Striated esophagus deglutitive motor function healthy adults

ACTIVE COMPARATOR

Testing of manometric, impedance and biomechanical measurements during swallowing in healthy volunteer adult subjects.

Device: Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction; Device: Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device

Striated esophagus deglutitive motor function in patients with ineffective esophageal motility

ACTIVE COMPARATOR

Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with ineffective esophageal motility.

Device: Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction; Device: Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device

Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometry

ACTIVE COMPARATOR

Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with symptoms of dysphagia but "normal" esophageal manometry by the Chicago Classification criteria.

Device: Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction; Device: Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device

Interventions

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

Striated esophagus deglutitive motor function healthy adults; Striated esophagus deglutitive motor function in patients with ineffective esophageal motility; Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometry

Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction DEVICE

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.

Striated esophagus deglutitive motor function healthy adults; Striated esophagus deglutitive motor function in patients with ineffective esophageal motility; Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometry

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53086, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Fluoroscopy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Reza Shaker

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Shaker, MD

CONTACT

4149556840; rshaker@mcw.edu

Mark Kern

CONTACT

4148053826; mkern@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Provost for Clinical and Translational Research, Senior Associate Dean, Director of Clinical and Translational Science Institute, Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology, Principal Investigator

Model Details: Testing the hypothesis that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics in health and disease.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 1, 2023
• Study Start: September 13, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)