High Resolution Pharyngeal Manometry (HRPM) Biofeedback
Part of paid clinical trials in New York, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT07508059
- Status
- Not Yet Recruiting
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Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 40 Years
- Healthy Volunteers
- Accepted
Interventions
- Swallowing Maneuvers — OTHERSwallows 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) — DIAGNOSTIC_TESTA diagnostic tool using a catheter with closely spaced sensors to measure pressures and timing within the pharynx and upper esophageal sphincter (UES) during swallowing
Study Details
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.
Key Dates
- Start date
- May 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Feb 1, 2027
- Completion
- May 1, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Swallowing Maneuvers with and without HRPM BiofeedbackParticipants 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.
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) ]
Central Contacts
- Sonja Molfenter212-992-7694
- Claire Crossman
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | - |
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