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

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

Timeline

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

Treatment Details

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.

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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Pharyngeal swallow adaptations to bolus volume measured with high-resolution manometry. [2021]

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

Quantitative Analysis of Swallowing Function Between Dysphagia Patients and Healthy Subjects Using High-Resolution Manometry. [2022]

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]

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

Effect of bolus volume on pharyngeal swallowing assessed by high-resolution manometry. [2014]

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]

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

High-resolution manometry: what about the pharynx? [2019]

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]

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

High-resolution impedance manometry parameters in the evaluation of esophageal function of non-obstructive dysphagia patients. [2022]