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Rehabilitation Manometry Study

NCT04130867 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2025-10-29

No results posted yet for this study

Summary

Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function.

This proposed project will address a central hypotheses that objective swallowing measures (including (pHRM) will reveal treatment-mediated swallowing changes, will align with patient-reported outcome measures, and will be able to predict who will benefit from treatment. The investigators will follow a cohort of participants with oropharyngeal dysphagia as they undergo either pharyngeal strengthening therapy or relief of upper esophageal sphincter outlet obstruction at three time points: baseline, mid-treatment (4-6 weeks) and post-treatment (10-12 weeks). The investigators will compare participants to healthy controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.

Conditions

  • Oropharyngeal Dysphagia

Interventions

PROCEDURE

pHRM

Pharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing.

PROCEDURE

VFSS

Videofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Timothy McCulloch, MD, FACS · University of Wisconsin, Madison

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2021-04-21
Completion
2021-04-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04130867 on ClinicalTrials.gov