Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4 participants
OBSERVATIONAL
2020-11-11
2021-04-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A: Swallow Therapy Oropharyngeal Strengthening
Participants receiving any standard of care swallow therapy with oropharyngeal strengthening as the primary goal
Participants will undergo pHRM, videofluoroscopy (VF), diet assessment, functional reserve tests, and patient--reported outcome questionnaires at 3 standardized time points: baseline, 4 to 6 weeks (mid therapy), and 10 to -12 weeks (post -therapy)
pHRM
Pharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing.
VFSS
Videofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement.
Group B: Surgical Treatment Esophageal Sphincter
Participants receiving surgical treatment for relief of upper esophageal sphincter outlet obstruction.
Participants will undergo pHRM, videofluoroscopy (VF), diet assessment, functional reserve tests, and patient--reported outcome questionnaires at 3 standardized time points: baseline, 4 to 6 weeks (mid therapy), and 10 to -12 weeks (post therapy)
pHRM
Pharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing.
VFSS
Videofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement.
Group C: Healthy Controls
Healthy controls (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm.
pHRM
Pharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing.
VFSS
Videofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement.
Interventions
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pHRM
Pharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing.
VFSS
Videofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement.
Eligibility Criteria
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Inclusion Criteria
* 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.\\
Exclusion Criteria
* 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)
18 Years
99 Years
ALL
Yes
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Timothy McCulloch, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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A539770
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/SURGERY/SURGERY*OT
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Ver 0.06, 1/16/2021
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0576
Identifier Type: -
Identifier Source: org_study_id
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