50 Participants NeededMy employer runs this trial

HRPM Biofeedback for Swallowing

SM
CC
Overseen ByClaire Crossman
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve swallowing skills using High Resolution Pharyngeal Manometry (HRPM) biofeedback. The goal is to determine if real-time visual feedback on a screen can make swallowing easier and more effective. It also examines participants' opinions on this biofeedback method. Ideal participants are young adults without a history of swallowing problems or therapy, who are open to trying this technology. As an unphased trial, it offers participants the opportunity to explore innovative technology and contribute to groundbreaking research in swallowing therapy.

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 HRPM biofeedback is safe for swallowing rehabilitation?

Research has shown that High Resolution Pharyngeal Manometry (HRPM) is generally well-tolerated by most people. In one study involving 133 adults using HRPM for the first time, participants reported the procedure as comfortable. This suggests that HRPM is safe for use as a tool to assist with swallowing. Available data indicate no major side effects associated with HRPM, making it a promising option for those seeking to improve their swallowing abilities.12345

Why are researchers excited about this trial?

Researchers are excited about HRPM Biofeedback for swallowing because it offers a new, interactive way to improve swallowing function. Unlike traditional treatments that might involve exercises or dietary modifications, this method uses high-resolution pharyngeal manometry to provide real-time feedback during swallowing exercises. This biofeedback mechanism allows patients to see how their muscles are working and make immediate adjustments, potentially speeding up the learning process and improving outcomes. This dynamic approach could lead to more effective and efficient rehabilitation for individuals with swallowing difficulties.

What evidence suggests that HRPM biofeedback is effective for swallowing rehabilitation?

Research has shown that High Resolution Pharyngeal Manometry (HRPM) biofeedback can improve swallowing. In this trial, participants will perform swallowing maneuvers both with and without HRPM biofeedback. Studies have found that HRPM provides visual feedback, helping patients understand and adjust their swallowing technique. This feedback can lead to better outcomes by allowing patients to see their swallowing performance and make necessary improvements. Specifically, it helps them fine-tune the strength and timing of their swallows, which are crucial for effective swallowing. Early findings suggest that incorporating HRPM in therapy can enhance the swallowing process and reduce issues related to dysphagia, or difficulty swallowing.12456

Who Is on the Research Team?

SM

Sonja Molfenter

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-40 who live independently, have no swallowing problems, and are willing to participate in study procedures.

Inclusion Criteria

I am between 18 and 40 years old.
I am willing to give consent and take part in the study.
I live independently in the community.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Acclimation and Procedure

Participants undergo a 2-minute acclimation period with the catheter in place, followed by swallowing maneuvers with and without HRPM biofeedback

5-8 minutes
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • High Resolution Pharyngeal Manometry (HRPM) Biofeedback

Trial Overview

The study tests whether using real-time visual feedback from a device called High Resolution Pharyngeal Manometry (HRPM) can help improve swallowing techniques during specific exercises compared to doing the exercises without this feedback.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Swallowing Maneuvers with and without HRPM BiofeedbackExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

The Utility of High-Resolution Pharyngeal Manometry in ...

Biofeedback in dysphagia treatment not only enhances the potential of pharyngeal proprioception to aid the patient in the correct implementation of clinical ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28231362/

The use of high-resolution pharyngeal manometry as ...

The use of high-resolution pharyngeal manometry as biofeedback in dysphagia therapy.

High-Resolution Pharyngeal Manometry - A New Tool for ...

Specifically, patients can use this visual input to monitor the effectiveness of their swallowing and refine their approach to improve outcomes.

The use of High-Resolution Pharyngeal Manometry as ...

Beyond its diagnostic capabilities, HRM has been shown to have potential utility in the treatment of dysphagia via guiding biofeedback therapy modalities. ...

Implementation of High-resolution Manometry in the Clinical ...

The goal of this article is to describe a clinical paradigm using HRM as an adjunct to VFSS, by the SLP, in the assessment of complex dysphagia.

Safety and Tolerability of Pharyngeal High-Resolution ...

Data were collected prospectively from 133 adult patients who underwent pharyngeal high-resolution manometry for the 1st time. Patients rated tolerability ...