External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing

NCT05708911 | Recruiting DMC FDA Device

• 1 other identifier: PRO00022959
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (11)

• laryngeal excursion during swallowing

  maximum laryngeal excursion from resting position measured from fluoroscopic images during swallowing

  During mano-fluorography procedure

• hyoid excursion during swallowing

  maximum hyoid bone excursion from resting position measured from fluoroscopic images during swallowing

  During mano-fluorography procedure

• upper esophageal sphincter (UES) opening during swallowing

  maximum UES anterior-posterior diameter measured from fluoroscopic images during swallowing

  During mano-fluorography procedure

• pharyngeal peak peristaltic pressure

  maximum deglutitive pressure within the pharynx

  During mano-fluorography procedure

• pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration

  manometric duration of peristaltic pressure wave in velopharynx, oropharynx and hypopharynx

  During mano-fluorography procedure

• pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral

  space-time and length integral of pharyngeal pressures in the velopharynx, oropharynx and hypopharynx

  During mano-fluorography procedure

• hypopharyngeal intrabolus pressure

  maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx

  During mano-fluorography procedure

• hypopharyngeal intrabolus duration

  duration of maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx

  During mano-fluorography procedure

• UES nadir pressure

  minimum pressure within the upper esophageal sphincter (UES) during UES deglutitive relaxation

  During mano-fluorography procedure

• UES relaxation time

  duration pressure drops within the upper esophageal sphincter during UES deglutitive relaxation

  During mano-fluorography procedure

• baseline UES pressure

  average UES pressure when no swallow activity is present

  During mano-fluorography procedure

Study Arms (1)

Pharyngeal exerciser group

EXPERIMENTAL

Test that application of the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing as evidenced manometrically by changes in Pharyngeal peak pressures Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral Hypopharyngeal intrabolus pressure and duration UES nadir pressure UES relaxation time Baseline UES pressure

Device: Pharyngeal exerciser

Interventions

Pharyngeal exerciser DEVICE

Pharyngo-esophageal manometry during lateral fluoroscopy

Pharyngeal exerciser group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers must be at least 18 years of age or older.

You may not qualify if:

• Subjects with cervical spine disorders.
• Subjects with neurological disorders like dementia, cerebrovascular diseases other than Parkinson's Disease
• Subjects with carotid artery bruit or carotid vascular disorders.
• Subjects suffering from muscle diseases like muscular dystrophies, myopathies.
• Subjects with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders.
• Subjects with any current esophageal symptoms like heartburn, dysphagia, chest pain or regurgitation.
• Subjects cannot have previous head or neck surgery or radiation.
• Subjects unable to tolerate nasal intubation.
• Subjects with significant bleeding disorders for whom nasal intubation has been deemed contraindicated.
• Subjects with a known upper airway or esophageal obstruction preventing the passage of the manometry probe.
• Subjects with autonomic dysfunction.
• Subjects having a history of allergy to lidocaine and barium.
• Subjects who are pregnant or lactating.
• Subjects who have advanced medical disorders (e.g.: chronic obstructive pulmonary disease (COPD), congestive heart failure, cirrhosis, cancer, chronic renal failure, etc.).
• Subjects who are medically unstable.

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Reza Shaker, MD

  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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Provost for Clinical and Translational Research, Senior Associate Dean and Director of the Clinical and Translational Science Institute of SE WI, and the Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology

Model Details: Study of healthy subjects

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 1, 2023
• Study Start: September 16, 2014
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)