Recruiting

Pharyngeal Exerciser

Sponsor:

Medical College of Wisconsin

Code:

NCT05708898

Conditions

Dysphagia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pharyngeal exerciser

sham pharyngeal exerciser

Study Details

Brief summary:

The goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in patients with dysphagia. The main question it aims to answer is:

•Does application of pharyngeal exerciser improve swallowing as evidenced by need for prescribed intervention for dysphagia (maneuvers, exercises or dietary modification to prevent aspiration).

Participants will:

  • Perform barium swallows in lateral view fluoroscopy
  • Over a six-week period, perform thrice daily sessions of swallowing with an external, laryngeal restriction device covering the larynx
  • Return for another fluoroscopic barium swallow study

Conditions

Dysphagia

Study ID

NCT05708898

Start date

Jun 9, 2015

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspiration

Healthy elderly adult (≥65 years of age).

Exclusion Criteria:

  • Patients younger than 18 years of age.

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

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pharyngeal exerciser group

In this group, the device will be placed around the neck overlying the laryngeal cartilage. Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks.

sham comparator: Sham exerciser group

In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.

Interventions

Pharyngeal exerciser

sham pharyngeal exerciser

Primary outcome measure

  • maximum anterior hyoid excursion [ Time Frame: Before six weeks exerciser regimen ]
  • maximum anterior hyoid excursion [ Time Frame: after six weeks exerciser regimen ]
  • maximum superior hyoid excursion [ Time Frame: Before six weeks exerciser regimen ]
  • maximum superior hyoid excursion [ Time Frame: after six weeks exerciser regimen ]
  • maximum anterior laryngeal excursion [ Time Frame: Before six weeks exerciser regimen ]
  • maximum anterior laryngeal excursion [ Time Frame: after six weeks exerciser regimen ]
  • maximum superior laryngeal excursion [ Time Frame: before six weeks exerciser regimen ]
  • maximum superior laryngeal excursion [ Time Frame: after six weeks exerciser regimen ]
  • maximum upper esophageal sphincter (UES) anterior-posterior opening [ Time Frame: Before six weeks exerciser regimen ]
  • maximum upper esophageal sphincter (UES) anterior-posterior opening [ Time Frame: after six weeks exerciser regimen ]
  • pyriform sinus residue [ Time Frame: Before six weeks exerciser regimen ]
  • pyriform sinus residue [ Time Frame: after six weeks exerciser regimen ]

Central Contacts and Locations

Central contacts

Reza Shaker, MD

4149556840rshaker@mcw.edu

Mark Kern

414-805-3826mkern@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53086

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Feb 12, 2026

Last verified

Feb, 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 2026-02-12.