RecruitingNot Applicable

Striated Esophageal Motor Function Modulation in Health and Disease

United States557 participantsStarted 2022-09-13

Plain-language summary

The investigators hypothesize that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

peak deglutitive pharyngeal peristaltic wave pressure

Timeframe: Before six weeks exerciser regimen, during deglutitive restriction of the larynx

peak deglutitive pharyngeal peristaltic wave pressure

Timeframe: After six weeks exerciser regimen, during deglutitive restriction of the larynx

hypopharyngeal intra-bolus

Timeframe: Before exerciser regimen, during deglutitive restriction of the larynx

hypopharyngeal intra-bolus

Timeframe: After exerciser regimen, during deglutitive restriction of the larynx

upper esophageal sphincter (UES) nadir pressure

Timeframe: Before six weeks exerciser regimen, during deglutitive restriction of the larynx

upper esophageal sphincter (UES) nadir pressure

Timeframe: After six weeks exerciser regimen, during deglutitive restriction of the larynx

pharyngeal contractile integral

Timeframe: Before six weeks exerciser regimen, during deglutitive restriction of the larynx

Trial details

NCT IDNCT05708885

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Reza Shaker, MD

4149556840 rshaker@mcw.edu

View on ClinicalTrials.gov More Dysphagia, Esophageal trials

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

peak deglutitive pharyngeal peristaltic wave pressure

Timeframe: Before six weeks exerciser regimen, during deglutitive restriction of the larynx

peak deglutitive pharyngeal peristaltic wave pressure

Timeframe: After six weeks exerciser regimen, during deglutitive restriction of the larynx

hypopharyngeal intra-bolus

Timeframe: Before exerciser regimen, during deglutitive restriction of the larynx

hypopharyngeal intra-bolus

Timeframe: After exerciser regimen, during deglutitive restriction of the larynx

upper esophageal sphincter (UES) nadir pressure

Timeframe: Before six weeks exerciser regimen, during deglutitive restriction of the larynx

upper esophageal sphincter (UES) nadir pressure

Timeframe: After six weeks exerciser regimen, during deglutitive restriction of the larynx

pharyngeal contractile integral

Timeframe: Before six weeks exerciser regimen, during deglutitive restriction of the larynx