External Pharyngeal Exerciser and Dysphagia
NCT05708898 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-02-12
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
Conditions
Interventions
- DEVICE
-
Pharyngeal exerciser
- DEVICE
-
sham pharyngeal exerciser
Sponsors & Collaborators
-
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Reza Shaker, MD · Medical College of Wisconsin
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-06-09
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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