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NCT Number: NCT07508059

High Resolution Pharyngeal Manometry (HRPM) Biofeedback

The purpose of this study is to quantify the added benefit of visual biofeedback from High Resolution Pharyngeal Manometry (HRPM) for swallowing rehabilitation. Primary aims including assessing changes in swallowing biomechanics (pressure generation, timing) during swallow maneuvers with and without HRPM visual biofeedback. Secondary aim includes participant attitudes related to visual biofeedback and the experience of HRPM.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be independent community dwelling adults.
  • Participants must be between the ages of 18-40 years old.
  • Willingness to consent and participate in the study procedures.
  • No reported dysphagia or difficulty swallowing evidenced by an EAT-10 Score <3.

Exclusion criteria

  • Known structural or neurological causes of dysphagia (e.g., stroke, brain injury, or head/neck cancer).
  • Recent or remote history of swallowing therapy; familiarity with swallowing maneuvers from relevant coursework as applicable (i.e., speech language pathology students).

Treatment and study plan

Swallowing Maneuvers

Other

Swallows will include 5 regular-effort saliva swallows (+/- visual biofeedback), 5 effortful saliva swallows (+/- visual biofeedback), 5 mendelsohn maneuver swallows (+/- visual biofeedback), and 5 masako or tongue hold maneuver swallows (+/- visual biofeedback).

High Resolution Pharyngeal Manometry (HRPM)

Diagnostic Test

A diagnostic tool using a catheter with closely spaced sensors to measure pressures and timing within the pharynx and upper esophageal sphincter (UES) during swallowing

Other names: Solar GI

Primary outcomes

  1. Change in pharyngeal contractile integral (PhCI) (mmHg) with and without visual biofeedback via HRPM

    Time frame: Baseline (without HRPM), with HRPM (up to 2 minutes)

    Pharyngeal contractile integral, a product of mean pharyngeal contractile amplitude, length, and duration. Low PhCI (< 100-150 mmHg·s·cm): Indicates hypo-contractility or weakness while High PhCI (> 200-300+ mmHg·s·cm): Represents stronger contraction strength

  2. Change in pharyngoesophageal Segment (PES) opening duration (ms) with and without visual biofeedback via HRPM

    Time frame: Baseline (without HRPM), with HRPM (up to 2 minutes)

    Measures the duration of Upper Esophageal Sphincter (UES) opening in milliseconds. Short Duration (<300ms) correlates with upper esophageal sphincter dysfunction, reduced laryngeal elevation, and poor pharyngeal contraction.

  3. Change in PES pressure with visual biofeedback via HRPM with and without visual biofeedback via HRPM

    Time frame: Baseline (without HRPM), with HRPM (up to 2 minutes)

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Crossman

CONTACT

[email protected]

Sonja Molfenter

CONTACT

[email protected]

212-992-7694

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Assessing the Impact of Biofeedback on Task Performance With Swallowing Maneuvers in Healthy Young Adults Using High Resolution Pharyngeal Manometry (HRPM)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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