NCT05708898 External Pharyngeal Exerciser and Dysphagia
| NCT ID | NCT05708898 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2015-06-09 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2015-06-09 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 fluoroscopy * Over a six-week period, perform thrice daily sessions of swallowing with an external, laryngeal restriction device covering the larynx * Return 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 aspiration Healthy 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 disorders Patients 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.
Contact & Investigator
Reza Shaker, MD
PRINCIPAL INVESTIGATOR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT05708898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05708898 currently recruiting?
Yes, NCT05708898 is actively recruiting participants. Contact the research team at rshaker@mcw.edu for enrollment information.
Where is the NCT05708898 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT05708898 clinical trial?
NCT05708898 is sponsored by Medical College of Wisconsin. The principal investigator is Reza Shaker, MD at Medical College of Wisconsin. The trial plans to enroll 160 participants.