Striated Esophageal Motor Function Modulation in Health and Disease
ConditionDysphagia, Esophageal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMedical College of Wisconsin
About this trial
The investigators hypothesize that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy subjects aged 18 to 90 years.
Patents with dysphagia but normal high resolution esophageal manometric findings defined by the Chicago classification.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction
DeviceTo 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.
Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device
DeviceUse 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.
Treatment groups
557 Participants
are divided into 3 treatment groupsGroup A: Striated esophagus deglutitive motor function healthy adultsActive comparator 2 interventions
Group B: Striated esophagus deglutitive motor function in patients with ineffective esophageal motilityActive comparator 2 interventions
Group C: Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometryActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
peak deglutitive pharyngeal peristaltic wave pressure
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)
Time frame
Before six weeks exerciser regimen, during deglutitive restriction of the larynx2
peak deglutitive pharyngeal peristaltic wave pressure
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)
Time frame
After six weeks exerciser regimen, during deglutitive restriction of the larynx3
hypopharyngeal intra-bolus
pressure within the swallowed bolus as it passes through the hypopharynx
Time frame
Before exerciser regimen, during deglutitive restriction of the larynx4
hypopharyngeal intra-bolus
pressure within the swallowed bolus as it passes through the hypopharynx
Time frame
After exerciser regimen, during deglutitive restriction of the larynxSponsors and contacts
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Source ClinicalTrials.gov