High Resolution Pharyngeal Manometry (HRPM) Biofeedback

NYU Langone Health50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Swallowing ManeuversOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants must be independent community dwelling adults. 2. Participants must be between the ages of 18-40 years old. 3. Willingness to consent and participate in the study procedures. 4. No reported dysphagia or difficulty swallowing evidenced by an EAT-10 Score \<3. Exclusion Criteria: 1. Known structural or neurological causes of dysphagia (e.g., stroke, brain injury, or head/neck cancer). 2. Recent or remote history of swallowing therapy; familiarity with swallowing maneuvers from relevant coursework as applicable (i.e., speech language pathology students).

Locations (1)

NYU Langone Health

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

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.

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

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)

Central Contacts

Sonja Molfenter

CONTACT

212-992-7694 Smm16@nyu.edu

Claire Crossman

CONTACT

Cmc9512@nyu.edu

Data from ClinicalTrials.gov

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