Striated Esophageal Motor Function Modulation in Health and Disease

Conditions

• Dysphagia, Esophageal

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Accepted

Interventions

• 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.
• 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.

Study Details

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

Key Dates

Start date

Sep 13, 2022

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

557 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

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.

Primary Outcome Measure

peak deglutitive pharyngeal peristaltic wave pressure [ Time Frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx ]

Central Contacts

• Reza Shaker, MD
  4149556840
  [email protected]
• Mark Kern
  4148053826
  [email protected]

Locations (1)

Find similar trials in Milwaukee, WI

Related Studies

• Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring
  Recruiting · Indiana University · Indianapolis, Indiana