Rehabilitation Manometry Study

University of Wisconsin, Madison4 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Oropharyngeal Dysphagia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion 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.\\ Exclusion Criteria: * 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)

Outcomes

Primary Outcomes

Change in pHRM from Baseline

pHRM data collected from the 250 adults undergoing dysphagia treatment and 50 healthy controls at three time points (baseline, mid-treatment, and post-treatment) will be used.

Time frame: up to 3 months

Change in Sydney Swallowing Questionnaire between timepoints

The Sydney Swallowing Questionnaire is a 17-item inventory scored on a visual analog scale (VAS) (with the exception of Q12) developed to measure symptomatic severity of pharyngeal dysphagia. Each VAS is 100 mm, where the left side of the scale is lesser symptoms and the right hand of the scale is increased symptoms. Scoring is measured in distance (mm) from the left. Maximum range in the scoring is 0 - 1700, the higher the score, the more severe the symptoms.