Recruiting

HRPM Biofeedback

Sponsor:

NYU Langone Health

Code:

NCT07508059

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Swallowing Maneuvers

High Resolution Pharyngeal Manometry (HRPM)

Study Details

Brief summary:

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.

Conditions

Healthy

Study ID

NCT07508059

Start date

Aug 19, 2026

Status verified date

Mar, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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).

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Sonja Molfenter

212-992-7694Smm16@nyu.edu

Claire Crossman

Cmc9512@nyu.edu

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 21, 2026

Last verified

Mar, 2026

Keywords

  • Swallow

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-21.