High Resolution Pharyngeal Manometry (HRPM) Biofeedback

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

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 Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Swallowing Maneuvers; Diagnostic test: High Resolution Pharyngeal Manometry (HRPM)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonja Molfenter; Phone Number: 212-992-7694; Email: Smm16@nyu.edu
• Study Contact Backup: Name: Claire Crossman; Email: Cmc9512@nyu.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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		Baseline (without HRPM), with HRPM (up to 2 minutes)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Sonja Molfenter, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Swallow
• Other Study ID Numbers: 25-01669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request immediately following publication, no end date, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: smm16@nyu.edu. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to smm16@nyu.edu. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes