NCT05708885 · Medical College of Wisconsin
Striated Esophageal Motor Function Modulation in Health and Disease
What this study is about
The investigators hypothesize that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics.
View original scientific description
The investigators hypothesize that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics.
Interventions
DEVICE
Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction
To reduce the laryngeal movement and St.Eso excursion we will use a device constructed in our laboratory which can induce an adjustable resistance to excursion of the larynx. This handmade device that is worn around the neck consists of a band and a concave plastic disk which serves as a support structure for an inflatable polyethylene bag which is connected to a hand pump and pressure gauge. When worn around the neck the inflatable bag rests in position on the thyroid cartilage with a portion of it hung over above the cartilage creating resistance to its superior excursion when fixed by closure straps. A known external force may be applied to the thyroid by partially inflating the bag to a specific pressure reading on the gauge. The soft and compliant bag conforms to the larynx while applying a resistive force to anterior and superior distraction of the hyolaryngeal complex during swallowing.
DEVICE
Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device
Use the previously mentioned wearable device (sRED) and exercise regimen described previously for studying the effect of increase in anterosuperior excursion of the larynx/St.Eso on St.Eso peristaltic function.
Primary outcome measures
peak deglutitive pharyngeal peristaltic wave pressure
Time frame: Before 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 pressure
Time frame: After 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-bolus
Time frame: Before exerciser regimen, during deglutitive restriction of the larynx
pressure within the swallowed bolus as it passes through the hypopharynx
hypopharyngeal intra-bolus
Time frame: After exerciser regimen, during deglutitive restriction of the larynx
pressure within the swallowed bolus as it passes through the hypopharynx
upper esophageal sphincter (UES) nadir pressure
Time frame: Before six weeks exerciser regimen, during deglutitive restriction of the larynx
minimum pressure during deglutitive UES relaxation
upper esophageal sphincter (UES) nadir pressure
Time frame: After six weeks exerciser regimen, during deglutitive restriction of the larynx
minimum pressure during deglutitive UES relaxation
pharyngeal contractile integral
Time frame: Before 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 integral
Time frame: After 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 complex
Time frame: Before 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 complex
Time frame: After 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 swallows
Time frame: Before 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 swallows
Time frame: After 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations