Air Bolus Effects for Swallowing Disorders

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical College of Wisconsin

Disqualifiers: Pharyngo-esophageal disease, Pregnancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Pharyngo-esophageal High-Resolution Manometry for swallowing disorders?

Research shows that high-resolution manometry (HRM) is useful for studying swallowing function and detecting swallowing disorders, as it measures pressure and movement in the throat and esophagus. This suggests HRM can help understand and potentially improve swallowing in patients with disorders. ^{1 2 3 4 5}

Is high-resolution manometry safe for humans?

High-resolution manometry (HRM) is generally well tolerated in humans, as it is a catheter-based method used to measure pressures during swallowing. ^{1 2 4 6 7}

How is the treatment Pharyngo-esophageal High-Resolution Manometry unique for swallowing disorders?

Pharyngo-esophageal High-Resolution Manometry (P-HRM-I) is unique because it uses advanced technology to measure pressure and movement in the throat and esophagus during swallowing, helping to understand how different bolus (swallowed material) volumes affect swallowing. This detailed analysis can provide insights that are not available with other treatments, making it a valuable tool for diagnosing and managing swallowing disorders. ^{1 2 4 5 8}

Eligibility Criteria

This trial is for individuals with swallowing disorders. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

I am between 21 and 90 years old.

I have never had throat or swallowing disorders.

Exclusion Criteria

I am under 21 years old.

I am over 90 years old.

Pregnancy

Treatment Details

Interventions

• Pharyngo-esophageal High-Resolution Manometry (Procedure)

Trial Overview The trial is studying how an air bolus affects the movement of muscles in the throat and esophagus using a technique called high-resolution manometry, which measures muscle pressure.

Participant Groups

Group I: Healthy adults Experimental Treatment 1 Intervention

Pharyngo-esophageal high resolution manometry with affixed single-lumen, end-hole catheter wherein one end of the single lumen catheter is in the pharynx and the other is connected to an external stopcock to vent or not vent the pharynx to atmosphere during twenty dry swallows (10 vented, 10 unvented).

Pharyngo-esophageal High-Resolution Manometry is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Pharyngeal High-Resolution Manometry for:

• Dysphagia
• Esophageal motility disorders
• Gastroesophageal reflux disease (GERD)
• Non-cardiac chest pain

🇪🇺 Approved in European Union as Pharyngeal High-Resolution Manometry for:

• Dysphagia
• Esophageal motility disorders
• Gastroesophageal reflux disease (GERD)
• Non-cardiac chest pain

🇨🇦 Approved in Canada as Pharyngeal High-Resolution Manometry for:

• Dysphagia
• Esophageal motility disorders
• Gastroesophageal reflux disease (GERD)
• Non-cardiac chest pain

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical College of Wisconsin Milwaukee, WI

Who Is Running the Clinical Trial?

Medical College of Wisconsin Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Pharyngeal swallow adaptations to bolus volume measured with high-resolution manometry. [2021] : To determine the effect of bolus volume on pharyngeal swallowing using high-resolution manometry (HRM).

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Quantitative Analysis of Swallowing Function Between Dysphagia Patients and Healthy Subjects Using High-Resolution Manometry. [2022] To compare swallowing function between healthy subjects and patients with pharyngeal dysphagia using high resolution manometry (HRM) and to evaluate the usefulness of HRM for detecting pharyngeal dysphagia.

3. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of a chin-down maneuver after esophagectomy on oropharyngeal swallowing pressure measured using high-resolution manometry. [2022] To elucidate the effects of a chin-down maneuver using high-resolution manometry (HRM) to measure pharyngeal swallowing pressure (SP) after esophagectomy.

4. United States pubmed.ncbi.nlm.nih.gov

Effect of bolus volume on pharyngeal swallowing assessed by high-resolution manometry. [2014] Solid-state high-resolution manometry (HRM) is fast becoming the gold standard for studying pharyngeal and esophageal motility. However, very few studies have ever evaluated the effect of bolus volume on the physiology of swallowing using HRM. We aimed to determine the effect of bolus volume on pressure, duration and velocity of the hypopharynx as well as the upper esophageal sphincter during pharyngeal swallowing using HRM.

5. Korea (South) pubmed.ncbi.nlm.nih.gov

The Effects of Bolus Volume and Texture on Pharyngeal Pressure Events Using High-resolution Manometry and Its Comparison with Videofluoroscopic Swallowing Study. [2020] The purpose of this study was to develop new parameters of high-resolution manometry (HRM) and to applicate these to quantify the effect of bolus volume and texture on pharyngeal swallowing.

6. United States pubmed.ncbi.nlm.nih.gov

High-resolution manometry: what about the pharynx? [2019] High-resolution pharyngeal manometry (HRPM) is a well tolerated, catheter-based, method for recording the pressures and bolus flow generated by the pharyngeal muscles during swallowing. Despite a body of published evidence and a critical mass of investigators in the field, there is a lack of consensus surrounding what biomechanical phenomena to measure. The purpose of this review is to provide some insights into the information on swallowing physiology that can be gathered using HRPM.

7. Brazil pubmed.ncbi.nlm.nih.gov

PHARYNGEAL, UPPER ESOPHAGEAL SPHINCTERIC AND ESOPHAGEAL PRESSURES RESPONSES RELATED TO VOCAL TASKS AT THE LIGHT OF HIGH RESOLUTION MANOMETRY. [2021] High-resolution manometry (HRM) represents a potential tool for measuring pharyngoesophageal phonation pressures.

8. England pubmed.ncbi.nlm.nih.gov

High-resolution impedance manometry parameters in the evaluation of esophageal function of non-obstructive dysphagia patients. [2022] High-resolution impedance manometry (HRIM) allows evaluation of esophageal bolus retention, flow, and pressurization. We explored novel HRIM measures and assessed their temporal relationship to dysphagia symptoms for boluses of different volume and consistency in non-obstructive dysphagia (NOD) patients.