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)
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started May 2026
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2026
CompletedFirst Posted
Study publicly available on registry
April 2, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 2, 2026
March 1, 2026
9 months
March 27, 2026
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
Study Arms (1)
Swallowing Maneuvers with and without HRPM Biofeedback
EXPERIMENTALParticipants 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
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).
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Sonja Molfenter
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2026
First Posted
April 2, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Immediately following publication. No end date.
- 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.
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.