Throat Exerciser for Swallowing Disorders

N/A

Recruiting

Led By Reza Shaker, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before six weeks exerciser regimen

Summary

This trial tests if a throat exerciser improves swallowing in people with difficulty swallowing. Participants use the exerciser 3x/day for 6wks & have their swallowing tested.

Who is the study for?

This trial is for healthy adults over 65 with swallowing difficulties, who have pharyngeal residue seen on a fluoroscopic study and are undergoing treatment to improve swallowing. It's not for those with cognitive impairments, muscle diseases, allergies to lidocaine or barium, neuro-muscular junction disorders, pregnant or lactating women, anyone unable to use the device independently or under 18.

What is being tested?

The trial tests if using a pharyngeal exerciser can help in rehabilitating the swallowing process in patients with dysphagia. Participants will use an external laryngeal restriction device three times daily for six weeks and undergo fluoroscopic barium swallow studies before and after this period.

What are the potential side effects?

Potential side effects may include discomfort from using the pharyngeal exerciser or reactions during the fluoroscopic barium swallow studies such as gagging or choking. Allergic reactions to materials used in the exerciser could also occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before six weeks exerciser regimen

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before six weeks exerciser regimen

This trial's timeline: 3 weeks for screening, Varies for treatment, and before six weeks exerciser regimen for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

maximum anterior hyoid excursion

maximum anterior laryngeal excursion

maximum superior hyoid excursion

+3 more

Secondary study objectives

Penetration and aspiration analyses

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pharyngeal exerciser groupExperimental Treatment1 Intervention

In this group, the device will be placed around the neck overlying the laryngeal cartilage. Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks.

Group II: Sham exerciser groupPlacebo Group1 Intervention

In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.

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