Modulating esophageal muscle function in healthy individuals and those with swallowing difficulties
Characterization of the Striated Esophagus (St.Eso) Deglutitive Motor Function and Its Modulation by Pharyngeal Phase Swallow Biomechanics
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 557 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05708885 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18 to 90 and patients with dysphagia who have normal esophageal manometric findings.
Not a fit: Patients with recent head and neck cancer, muscle diseases, or cognitive impairments may not benefit from this study.
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 performed: While this approach is innovative, similar studies using advanced imaging and manometry techniques have shown promise in understanding swallowing mechanics.
Eligibility criteria
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 this trial is running
Milwaukee, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.