Modulating esophageal muscle function in healthy individuals and those with swallowing difficulties
Official title: Characterization of the Striated Esophagus (St.Eso) Deglutitive Motor Function and Its Modulation by Pharyngeal Phase Swallow Biomechanics
Run by Medical College of Wisconsin · NCT05708885 · Data updated 2026-11-12
This study is testing a new device to see how changing the way we swallow can help healthy people and those with swallowing difficulties move food through their esophagus better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 557 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | September 13, 2022 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT05708885 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include healthy adults aged 18 to 90 and patients with dysphagia who have normal esophageal manometric findings.
✕Probably not a fit
Patients with recent head and neck cancer, muscle diseases, or cognitive impairments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how the motor function of the striated esophagus is influenced by the biomechanics of swallowing during the pharyngeal phase. Utilizing advanced techniques, including high-resolution manometry and impedance recording, the researchers will analyze pressure phenomena in the esophagus and pharynx. A novel device will be employed to non-invasively manipulate pharyngeal biomechanics, both positively and negatively, to assess its effects on swallowing. The study aims to gather objective measures of peristalsis and bolus movement through concurrent imaging techniques.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for patients with dysphagia by enhancing our understanding of esophageal motor function.
How similar studies have gone: While this approach is innovative, similar studies using advanced imaging and manometry techniques have shown promise in understanding swallowing mechanics.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy subjects aged 18 to 90 years. * Patents with dysphagia but normal high resolution esophageal manometric findings defined by the Chicago classification. Exclusion Criteria: * 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.
Where it's running
-
Medical College of Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Reza Shaker — Medical College of Wisconsin
- Study coordinator: Reza Shaker, MD
- Email: rshaker@mcw.edu
- Phone: 4149556840
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.