COMPLETED

Rehabilitation Manometry Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-11-11
Study Completion:2021-04-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04130867

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathological Group
  2. * 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:
  3. * Therapy to strengthen oropharyngeal musculature
  4. * Medical or surgical management to relieve an obstruction at the upper esophageal sphincter
  5. * Must agree to comply with swallowing assessment, including interview and manometry
  6. * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin
  7. * Normal Group
  8. * Having no swallowing disorders
  9. * Must agree to comply with swallowing assessment, including interview and manometry
  10. * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin.\\
  1. * Pathological Group
  2. * Therapeutic management plan already initiated prior to recruitment
  3. * Therapy goals including only improvement of swallowing coordination
  4. * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  5. * Positive history of allergic response to topical anesthetic
  6. * Allergy to food relevant to study participation (e.g. lactose intolerance)
  7. * Normal Group
  8. * Known swallowing disorder
  9. * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  10. * Positive history of allergic response to topical anesthetic
  11. * Allergy to food relevant to study participation (e.g. lactose intolerance)

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-11
Study Completion Date2021-04-21

Study Record Updates

Study Start Date2020-11-11
Study Completion Date2021-04-21

Terms related to this study

Additional Relevant MeSH Terms

  • Oropharyngeal Dysphagia