Studying Swallowing Function in Healthy Individuals and Those with Dysphagia

This study is looking at how swallowing muscles work in healthy people and those with difficulty swallowing (dysphagia). Researchers want to understand if the way your throat moves during swallowing affects how food or liquid travels down your esophagus (the tube connecting your throat to your stomach). They will use a special device worn around the neck to gently adjust throat movement, along with imaging and pressure measurements. The study aims to see if this device, used for six weeks as an exercise, can improve swallowing function. Success will be measured by changes in pressure waves in your throat during swallowing. You can join if you are 18 to 90 years old and are either healthy or have dysphagia with normal esophageal test results. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 557 participants. It involves using a device to modulate throat movement and another device for a six-week exercise regimen.
What's involved
You would undergo concurrent manometry/impedance (pressure and flow measurements) and fluoroscopy (X-ray imaging) with and without a laryngeal restriction device. Some participants will also use a swallow muscle exercising device for six weeks, with measurements taken before and after this period.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken before and after a six-week exercise regimen, and during deglutitive restriction of the larynx (throat movement). The duration of follow-up after these measurements is not specified.

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NCT05708885

Striated Esophageal Motor Function Modulation in Health and Disease

Recruiting
NAAges 18–90InterventionalBasic science
Medical College of Wisconsin
~557 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Concurrent manometry/impedance and fluoroscopy with and without laryngeal restrictionConcurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
peak deglutitive pharyngeal peristaltic wave pressure
Measured over Before six weeks exerciser regimen, during deglutitive restriction of the larynx
+11 more outcomes measured
Dysphagia, Esophageal
1 sites across 1 states
Wisconsin1
  • Reza Shaker · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

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Eligibility criteria

Inclusion

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

Exclusion

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.
  • peak deglutitive pharyngeal peristaltic wave pressureBefore six weeks exerciser regimen, during deglutitive restriction of the larynx

    Peak deglutitive pharyngeal peristaltic wave pressure will be measured at positions 2-8cm above the upper margin of the manometrically determined upper esophageal sphincter high-pressure zone (UESHPZ)

  • peak deglutitive pharyngeal peristaltic wave pressureAfter six weeks exerciser regimen, during deglutitive restriction of the larynx

    Peak deglutitive pharyngeal peristaltic wave pressure will be measured at positions 2-8cm above the upper margin of the manometrically determined upper esophageal sphincter high-pressure zone (UESHPZ)

  • hypopharyngeal intra-bolusBefore exerciser regimen, during deglutitive restriction of the larynx

    pressure within the swallowed bolus as it passes through the hypopharynx

  • hypopharyngeal intra-bolusAfter exerciser regimen, during deglutitive restriction of the larynx

    pressure within the swallowed bolus as it passes through the hypopharynx

  • upper esophageal sphincter (UES) nadir pressureBefore six weeks exerciser regimen, during deglutitive restriction of the larynx

    minimum pressure during deglutitive UES relaxation

  • upper esophageal sphincter (UES) nadir pressureAfter six weeks exerciser regimen, during deglutitive restriction of the larynx

    minimum pressure during deglutitive UES relaxation

  • pharyngeal contractile integralBefore six weeks exerciser regimen, during deglutitive restriction of the larynx

    Time-space integral of the pharynx during swallows as measured from the manometric display

  • pharyngeal contractile integralAfter six weeks exerciser regimen, during deglutitive restriction of the larynx

    Time-space integral of the pharynx during swallows as measured from the manometric display

  • maximum excursion of the hyo-laryngeal complexBefore six weeks exerciser regimen, during deglutitive restriction of the larynx

    maximum deglutitive excursion of the hyoid and larynx from the pre-swallow resting position as measured from fluoroscopic images

  • maximum excursion of the hyo-laryngeal complexAfter six weeks exerciser regimen, during deglutitive restriction of the larynx

    maximum deglutitive excursion of the hyoid and larynx from the pre-swallow resting position as measured from fluoroscopic images

  • UES anterior-posterior maximum diameter during swallowsBefore six weeks exerciser regimen, during deglutitive restriction of the larynx

    maximum deglutitive diameter in the anterior-posterior direction of the UES measured from fluoroscopic images

  • UES anterior-posterior maximum diameter during swallowsAfter six weeks exerciser regimen, during deglutitive restriction of the larynx

    maximum deglutitive diameter in the anterior-posterior direction of the UES measured from fluoroscopic images