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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Swallowing Maneuvers with and without HRPM Biofeedback 		Participants will then undergo a 2-minute period of acclimation with the catheter in place prior to initiating the swallowing protocol and turning on the video biofeedback. Participants will then complete swallowing maneuvers, with 20 seconds between each swallow. The duration of the procedure from catheter placement to removal will be approximately 5-8 minutes.
  • Other: Swallowing Maneuvers
    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).
  • Diagnostic Test: High Resolution Pharyngeal Manometry (HRPM)
    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

Recruiting Locations

NYU Langone Health
New York, New York 10016

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Sonja Molfenter
212-992-7694
Smm16@nyu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.