High Resolution Pharyngeal Manometry (HRPM) Biofeedback
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Swallowing Maneuvers, High Resolution Pharyngeal Manometry (HRPM).
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessing the Impact of Biofeedback on Task Performance With Swallowing Maneuvers in Healthy Young Adults Using High Resolution Pharyngeal Manometry (HRPM)
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.
Interventions
- 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
Primary outcome measures
- 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)]
- 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)]
- 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)]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07508059 · 25-01669