Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT05708885

Conditions

Dysphagia, Esophageal

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction

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

Study Details

Brief summary:

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

Conditions

Dysphagia, Esophageal

Study ID

NCT05708885

Start date

Sep 13, 2022

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

557 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Striated esophagus deglutitive motor function healthy adults

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

active comparator: Striated esophagus deglutitive motor function in patients with ineffective esophageal motility

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

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

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.

Interventions

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.

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.

Primary outcome measure

  • peak deglutitive pharyngeal peristaltic wave pressure [ Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx ]
  • peak deglutitive pharyngeal peristaltic wave pressure [ Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx ]
  • hypopharyngeal intra-bolus [ Time Frame: Before exerciser regimen, during deglutitive restriction of the larynx ]
  • hypopharyngeal intra-bolus [ Time Frame: After exerciser regimen, during deglutitive restriction of the larynx ]
  • upper esophageal sphincter (UES) nadir pressure [ Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx ]
  • upper esophageal sphincter (UES) nadir pressure [ Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx ]
  • pharyngeal contractile integral [ Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx ]
  • pharyngeal contractile integral [ Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx ]
  • maximum excursion of the hyo-laryngeal complex [ Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx ]
  • maximum excursion of the hyo-laryngeal complex [ Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx ]
  • UES anterior-posterior maximum diameter during swallows [ Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx ]
  • UES anterior-posterior maximum diameter during swallows [ Time Frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx ]

Central Contacts and Locations

Central contacts

Reza Shaker, MD

4149556840rshaker@mcw.edu

Mark Kern

4148053826mkern@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53086

Contacts

Reza Shaker, MD

4149556840rshaker@mcw.edu

Mark Kern

4148053826mkern@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-05-05.