Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT05696184

Conditions

GERD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy

Slow and rapid intra-esophageal infusion

Study Details

Brief summary:

The overall goal is to define and characterize the manometric characteristics of UES incompetence associated with objectively documented pharyngeal reflux. The investigators will use endoscopic reflux detection as gold standard.

Conditions

GERD

Study ID

NCT05696184

Start date

Nov 1, 2013

Status verified date

Feb, 2026

Completion date

Oct 12, 2026

Anticipated

Primary completion date

Oct 12, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18 to 85

  • GERD patients with complaints of regurgitation and supra-esophageal symptoms will be included and recruited from our GI \& Otolaryngology clinics
  • GERD patients without complaint of supra-esophageal symptoms and regurgitation will be included and recruited from our GI \& Otolaryngology clinics
  • Asthma patients with and without supra-esophageal symptoms will be included and recruited from clinics affiliated with Medical College of Wisconsin. Asthma patients with the following classifications of asthma severity will be included: intermittent, mild persistent, moderate persistent, and severe persistent (as long as no acute asthma exacerbation at the time of the study)
  • Patient definition will be based on position statement and technical reviews of the American Gastroenterological Association and Montreal definition and classification of gastroesophageal and reflux disease (Am J Gastroenterol. 2006;101:1900-1920).
  • SERD is defined as patients on long term acid suppressive therapy complaining of persistent regurgitation along with supra-esophageal manifestations such as burning throat, asthma, chronic cough, or hoarseness. Patients will be screened by Reflux Symptom Index > 13.
  • Barrett's esophagus patients will be recruited based on histological diagnosis from previous endoscopic biopsy that will be found using the clinical database warehouse.

Exclusion Criteria:

  • Age <18 or >85

  • Active alcohol or drug abuse
  • History of ear, nose, throat and pulmonary diseases suspected of being GERD induced
  • History of head and neck malignancy and chemo-radiation therapy to the head and neck
  • Unable to give consent
  • Pregnant women (see justification in the Women and Minority Inclusion in Clinical Research section)
  • History of allergy to Lidocaine for nasal topical anesthesia
  • Allergy to green food dye
  • Asthma patients with an acute asthma exacerbation with symptoms including breathlessness, wheezing, and chest tightness

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD)

GERD patients with complaint of regurgitation and one of the following supra-esophageal symptoms attributed to reflux of gastric content: chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis and dental erosion i.e. SE-GERD. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

active comparator: Age and gender matched healthy controls

Controls will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

active comparator: Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint)

Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

active comparator: Asthma patients with and without supra-esophageal symptoms

Asthma patients with and without supra-esophageal symptoms (these symptoms include chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis, and dental erosion). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

active comparator: Age and gender matched patient controls for diagnosed Barrett's esophagus patients

Patient controls for diagnosed Barrett's esophagus patients. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Interventions

Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy

Combined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally.

Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images.

Slow and rapid intra-esophageal infusion

A 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise.

Primary outcome measure

  • Pressure Data Analysis [ Time Frame: During simulated reflux perfusion of the esophagus ]
  • Videoendoscopic data analysis [ Time Frame: During simulated reflux perfusion of the esophagus ]

Central Contacts and Locations

Central contacts

Reza Shaker, MD

4149556840rshaker@mcw.edu

Mark Kern

4148053826mkern@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53086

Contacts

Reza Shaker, MD

4149556840rshaker@mcw.edu

Mark Kern

4148053826mkern@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-02-10.