Air Bolus Effects for Swallowing Disorders

Overseen By Mark Kern

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Pharyngo-esophageal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand swallowing by examining how a small amount of air or liquid (a bolus) moves from the throat into the upper esophagus. Researchers use pharyngo-esophageal high-resolution manometry, a diagnostic procedure, to measure muscle movements during swallowing. Healthy individuals with no history of swallowing or upper esophagus problems are ideal candidates for this study. As an unphased trial, it offers participants the chance to contribute to foundational research that may enhance understanding of swallowing mechanisms.

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 prior data suggests that this method is safe for swallowing disorders?

Research has shown that the technique used in this trial, called pharyngeal high-resolution manometry, is generally safe. This method measures pressure in the throat and esophagus to help understand swallowing problems.

Studies have found that most people tolerate this technique well, experiencing no significant issues. Reports of serious side effects are absent. Primarily, it is used to diagnose and study swallowing disorders. Therefore, for those considering participation, the procedure is considered safe based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike current treatments for swallowing disorders, which often involve dietary modifications or physical therapy exercises, Pharyngo-esophageal High-Resolution Manometry offers a new way to understand and potentially address the condition. This technique uses a specialized catheter to measure pressure changes in the throat and esophagus, providing precise data on how these areas function during swallowing. Researchers are excited because this could lead to more personalized and effective treatments by pinpointing the exact nature of the swallowing issue. By venting or not venting the pharynx during swallows, this method may reveal critical insights into the mechanics of swallowing, offering a clearer picture than existing methods.

What evidence suggests that Pharyngo-esophageal High-Resolution Manometry is effective for swallowing disorders?

Research shows that pharyngeal high-resolution manometry (PHRM) helps understand swallowing problems by measuring throat muscle function during swallowing. This tool detects issues in the upper esophagus (the tube connecting the throat to the stomach) that other tests might miss. Studies have found that PHRM identifies swallowing problems even in people without obvious symptoms. By using this technology, doctors can better understand and treat swallowing disorders. Although more research is needed, early findings suggest it could be useful in diagnosing and managing these conditions. Participants in this trial will undergo pharyngo-esophageal high-resolution manometry to further explore its effects on swallowing disorders. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Study Procedure

Participants undergo pharyngo-esophageal high resolution manometry with affixed single-lumen, end-hole catheter for twenty dry swallows (10 vented, 10 unvented).

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pharyngo-esophageal High-Resolution Manometry

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

In a study involving 34 healthy subjects, it was found that larger bolus volumes (3 ml, 5 ml, and 10 ml) significantly increased the residual pressure and relaxation duration of the upper esophageal sphincter (UES) during swallowing, indicating that bolus size affects UES function.

However, the study revealed that bolus volume did not significantly impact the maximum pressures or pressure dynamics in the hypopharynx, suggesting that while UES behavior changes with volume, the hypopharyngeal response remains consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of bolus volume on pharyngeal swallowing assessed by high-resolution manometry. Lin, T., Xu, G., Dou, Z., et al.[2014]

High resolution manometry (HRM) effectively distinguishes between healthy individuals and patients with pharyngeal dysphagia, showing significant differences in pressure and timing parameters at key swallowing sites, such as the velopharynx and upper esophageal sphincter.

Specific HRM parameters, such as maximal VP pressure and TB pressure, have high sensitivity (over 96%) for identifying dysphagia, indicating that HRM can be a reliable diagnostic tool for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Analysis of Swallowing Function Between Dysphagia Patients and Healthy Subjects Using High-Resolution Manometry. Park, CH., Kim, DK., Lee, YT., et al.[2022]

In a study of 9 patients who underwent esophagectomy, the chin-down maneuver significantly lowered maximum swallowing pressure at the velopharynx, which may affect swallowing dynamics.

The chin-down position prolonged the duration of lowered swallowing pressure at the upper esophageal sphincter, potentially improving bolus passage by enhancing laryngeal elevation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a chin-down maneuver after esophagectomy on oropharyngeal swallowing pressure measured using high-resolution manometry. Matsubara, K., Kumai, Y., Miyamoto, T., et al.[2022]

High-resolution pharyngeal manometry (HRPM) is an effective and well-tolerated method for objectively measuring swallowing mechanics, including pressures and bolus flow, which can aid in diagnosing swallowing disorders.

Key measurements from HRPM, such as pharyngeal luminal occlusive forces and bolus flow timing, contribute to the Swallow Risk Index, providing valuable insights into swallowing function and its clinical implications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution manometry: what about the pharynx? Omari, T., Schar, M.[2019]

The study found that bolus volume significantly affects pharyngeal pressure and timing during swallowing, as demonstrated by high-resolution manometry (HRM) in 10 healthy subjects.

In contrast, the texture of the bolus did not have a significant impact on pharyngeal swallowing, indicating that volume is a more critical factor than texture in this context.

NCBI (Pubmed)

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. Ryu, JS., Park, D., Oh, Y., et al.[2020]

A study involving 12 subjects showed that different bolus volumes significantly affect pharyngeal swallowing dynamics, including pressure and timing of key events during swallowing.

As bolus volume increased, measures such as velopharyngeal pressure duration and upper esophageal sphincter (UES) opening duration also increased, which can help inform treatment strategies for patients with swallowing difficulties (dysphagia).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharyngeal swallow adaptations to bolus volume measured with high-resolution manometry. Hoffman, MR., Ciucci, MR., Mielens, JD., et al.[2021]

In a study involving 12 professional singers, high-resolution manometry (HRM) revealed that esophageal pressures significantly increase during vocalization compared to rest, indicating a physiological response during phonation.

The study also found that while pharyngeal and upper esophageal sphincter (UES) pressures did not significantly differ from rest, there was a notable increase in UES pressure during phonation, highlighting the role of the UES in vocalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PHARYNGEAL, UPPER ESOPHAGEAL SPHINCTERIC AND ESOPHAGEAL PRESSURES RESPONSES RELATED TO VOCAL TASKS AT THE LIGHT OF HIGH RESOLUTION MANOMETRY. Vaiano, T., Herbella, FAM., Behlau, M.[2021]

In a study of 33 non-obstructive dysphagia (NOD) patients, high-resolution impedance manometry (HRIM) revealed that bolus perception increased with the consistency of the bolus, indicating that thicker substances are more likely to be noticed by patients.

Patients with esophagogastric junction outflow obstruction (EGJOO) showed higher levels of bolus retention and restricted esophageal emptying compared to those with minor or no peristalsis disorders, suggesting that these HRIM measures could help identify abnormal swallowing patterns and improve understanding of dysphagia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution impedance manometry parameters in the evaluation of esophageal function of non-obstructive dysphagia patients. Singendonk, MJ., Lin, Z., Scheerens, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9643180/

Use of Pharyngeal High-Resolution Manometry to Evaluate ... Pharyngeal high-resolution manometry (PHRM) can quantify swallowing pathophysiology to inform and evaluate proactive dysphagia intervention.

2. theajo.com theajo.com/article/view/4563/html

Clinical application of pharyngeal high-resolution ... Pharyngeal high-resolution manometry with impedance (P-HRM-I) is an emerging, ambulatory swallow assessment for patients with pharyngeal dysphagia.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2444382424000646

High-resolution manometry with impedance for the study of ... A fundamental technique for better understanding the pathophysiology of pharynx and upper oesophageal sphincter (UES) dysfunctions in patients with OD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3479249/

High-resolution Manometry: Esophageal Disorders Not ... This review describes findings in HRM which are not included in the current Chicago classification based on the experience in our center.

5. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/full/10.1002/oto2.70168

Utility of High‐Resolution Esophageal Manometry in the ... HREM identified esophageal pathologies in 58.6% of patients with OD symptoms and normal MBSS, highlighting its value in the diagnostic workup of ...

6. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2019_PERS-SIG13-2018-0007

Translating High-Resolution Manometry From Research to ... HRM offers pressure measurement over time that can capture details of pharyngeal and upper esophageal sphincter function unattainable with current dysphagia ...