Standardizing Swallow Pressure Measurements
This study is comparing two different medical devices, the Laborie LMT Pharyngeal System and the Medtronic ManoScan ESO HRM System, which are used to measure swallowing pressure. Researchers want to see how differences in these devices, like the size of their catheters (thin tubes), affect the measurements. The goal is to understand if these devices give similar results when measuring how well people swallow. You could be eligible if you are between 18 and 99 years old and do not have any known swallowing problems. The study is looking for 25 healthy adults and is currently unclear about its recruitment status.
- Study design
- This is an interventional study involving 25 healthy adult volunteers. It directly compares two different medical devices in the same setting.
- What's involved
- You would participate in a single study visit lasting up to 2 hours. During this visit, swallowing pressure measurements will be taken.
- Compensation
- Not stated in the trial record.
- Follow-up
- Data will be collected during your single study visit. The study will be open for data collection for one year and data analysis for two years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Standardizing Swallow Pressure Measurements
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Timothy McCulloch, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Base of tongue pressuredata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Hypopharyngeal peak pressuredata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Pharyngeal Contractile Integral (PhCI)data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Pressure rise timedata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Contractile front velocitydata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Upper Esophageal Sphincter (UES) resting pressuredata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- UES peak contraction pressuredata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- UES relaxation nadir pressuredata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- UES relaxation durationdata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Nadir impedancedata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Bolus presence timedata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Flow intervaldata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Pressure-flow index componentdata collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Timing relationships (onset-to-peak intervals)data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
- Construction of Spatial pressure distribution mapsdata collected during 1 study visit (up to 2 hours)
Multi-level modeling for repeated measures across bolus types, volumes, and repetitions. Sensor-level and region-level analyses (BOT, hypopharynx, UES). Agreement thresholds and bias definitions added to facilitate interpretability and ensure clarity for cross-platform comparison. Map layers will be summarized as a proxy for this measure.