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NCT05708898
External Pharyngeal Exerciser and Dysphagia
Conditions: Dysphagia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 160
Sponsor: Medical College of Wisconsin
Location: United States
Summary
The goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in patients with dysphagia.
The main question it aims to answer is:•Does application of pharyngeal exerciser improve swallowing as evidenced by need for prescribed intervention for dysphagia (maneuvers, exercises or dietary modification to prevent aspiration).Participants will:Perform barium swallows in lateral view fluoroscopyOver a six-week period, perform thrice daily sessions of swallowing with an external, laryngeal restriction device covering the larynxReturn for another fluoroscopic barium swallow study
Eligibility Criteria
Inclusion Criteria:Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspirationHealthy elderly adult (≥65 years of age).Exclusion Criteria:Patients younger than 18 years of age.Patients with recent head and neck cancer (<1 month post-surgery or <3 months post-chemo radiation.Patients suffering from muscle diseases like muscular dystrophies, myopathies.Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disordersPatients having history of allergy to lidocaine or barium.Patients who are pregnant or lactating.Patients who are medically unstable.Patients who are unable to apply the exerciser independently or with the help of a caregiver.Patients who lack cognition.
Source: ClinicalTrials.gov (NCT05708898). StuddyBuddy aggregates publicly available trial information.