CompletedNot Applicable

Rehabilitation Manometry Study

United States4 participantsStarted 2020-11-11

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Posi…

What they're measuring

Change in pHRM from Baseline

Timeframe: up to 3 months

Change in Sydney Swallowing Questionnaire between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks

Change in Eat Assessment Tool Score between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks

Change in Hand Grip Strength Test between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks

Change in Maximum Isometric Pressure between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks

Change in Dietary Assessment between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks

Trial details

NCT IDNCT04130867

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-04-21

View on ClinicalTrials.gov More Oropharyngeal Dysphagia trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in pHRM from Baseline

Timeframe: up to 3 months

Change in Sydney Swallowing Questionnaire between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks

Change in Eat Assessment Tool Score between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks

Change in Hand Grip Strength Test between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks

Change in Maximum Isometric Pressure between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks

Change in Dietary Assessment between timepoints

Timeframe: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks