Rehabilitation Manometry Study

Description

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

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Study Overview

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Study Details

Study overview

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.

Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry

Rehabilitation Manometry Study

Condition
Oropharyngeal Dysphagia
Intervention / Treatment

-

Contacts and Locations

Madison

University of Wisconsin, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pathological Group
  • * Must have dysphagia as diagnosed by a licensed and certified otolaryngologist, gastroenterologist, or speech-language pathologist AND must have a dysphagia treatment plan that includes one of the following primary goals:
  • * Therapy to strengthen oropharyngeal musculature
  • * Medical or surgical management to relieve an obstruction at the upper esophageal sphincter
  • * Must agree to comply with swallowing assessment, including interview and manometry
  • * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin
  • * Normal Group
  • * Having no swallowing disorders
  • * Must agree to comply with swallowing assessment, including interview and manometry
  • * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin.\\
  • * Pathological Group
  • * Therapeutic management plan already initiated prior to recruitment
  • * Therapy goals including only improvement of swallowing coordination
  • * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  • * Positive history of allergic response to topical anesthetic
  • * Allergy to food relevant to study participation (e.g. lactose intolerance)
  • * Normal Group
  • * Known swallowing disorder
  • * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  • * Positive history of allergic response to topical anesthetic
  • * Allergy to food relevant to study participation (e.g. lactose intolerance)

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Wisconsin, Madison,

Timothy McCulloch, MD, FACS, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

2026-01