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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• 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.\

Locations
United States
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Suzan Abdelhalim, MD, MPH
abdelhalim@surgery.wisc.edu
608-265-2470
Time Frame
Start Date: 2020-11-11
Estimated Completion Date: 2026-01
Participants
Target number of participants: 300
Treatments
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)
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)
Group C: Healthy Controls
Healthy controls (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm.
Related Therapeutic Areas
Sponsors
Leads: University of Wisconsin, Madison

This content was sourced from clinicaltrials.gov