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Study of an External Pharyngeal Exerciser for Swallowing

This study is looking at how an external pharyngeal exerciser (a device worn around the neck) affects the muscles involved in swallowing. Researchers want to see if this device can increase the work these muscles do. They will measure how much your voice box (larynx) and a bone in your neck (hyoid) move during swallowing, and how much your upper esophageal sphincter (UES), a muscle that opens to let food into your stomach, opens. This study is for healthy volunteers between 18 and 85 years old. You cannot participate if you have certain neck or neurological conditions. The study aims to understand the effects of the pharyngeal exerciser on swallowing pressure.

Study design
This interventional study plans to enroll 60 healthy volunteers. It is not specified if it is randomized or blinded.
What's involved
You will need to fast for at least 3 hours before the study. Measurements of your neck and the device will be taken, and a small tube will be placed through your nose into your throat to measure pressure. You will then perform various swallows (dry, water, mashed potato) with the device at different pressure settings.
Compensation
Not stated in the trial record.
Follow-up
Measurements of laryngeal excursion, hyoid excursion, and upper esophageal sphincter (UES) opening are taken during the mano-fluorography procedure, which is the main study visit.

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NCT05708911

External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing

Recruiting
NAAges 18–85InterventionalTreatment
Medical College of Wisconsin
~60 participants
Updated 2026-01-14 on ClinicalTrials.gov
What's tested:Pharyngeal exerciser

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
laryngeal excursion during swallowing
Measured over During mano-fluorography procedure
+10 more outcomes measured

Conditions

Dysphagia

Explore related trials

Dysphagia

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Reza Shaker, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Reza Shaker, MD
[email protected]
4149556840
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • laryngeal excursion during swallowingDuring mano-fluorography procedure

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

  • hyoid excursion during swallowingDuring mano-fluorography procedure

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

  • upper esophageal sphincter (UES) opening during swallowingDuring mano-fluorography procedure

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

  • pharyngeal peak peristaltic pressureDuring mano-fluorography procedure

    maximum deglutitive pressure within the pharynx

  • pharyngeal (velopharynx, oropharynx and hypopharynx) contractile durationDuring mano-fluorography procedure

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

  • pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integralDuring mano-fluorography procedure

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

  • hypopharyngeal intrabolus pressureDuring mano-fluorography procedure

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

  • hypopharyngeal intrabolus durationDuring mano-fluorography procedure

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

  • UES nadir pressureDuring mano-fluorography procedure

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

  • UES relaxation timeDuring mano-fluorography procedure

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

  • baseline UES pressureDuring mano-fluorography procedure

    average UES pressure when no swallow activity is present