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Behavioural Intervention
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 after six weeks exerciser regimen
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 ~ after six weeks exerciser regimen
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after six weeks exerciser regimen
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
maximum anterior hyoid excursion
maximum anterior laryngeal excursion
maximum superior hyoid excursion
+3 moreSecondary outcome measures
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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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,423 Total Patients Enrolled
Reza Shaker, MDPrincipal InvestigatorMedical College of Wisconsin
3 Previous Clinical Trials
469 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a muscle disease such as muscular dystrophy or myopathy.You have difficulty swallowing which can be seen during a special X-ray test and are currently receiving treatment to improve your ability to swallow and prevent food or liquid from entering your lungs.You have had an allergic reaction to lidocaine or barium in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Pharyngeal exerciser group
- Group 2: Sham exerciser group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to become involved in the research project?
"Affirmative. Clinicaltrials.gov documents the fact that this clinical trial, which was initially listed on June 9th 2015 is still recruiting candidates. The research requires 160 individuals to be recruited from 1 particular site."
Answered by AI
What is the limit to the amount of participants this research can accommodate?
"Affirmative. According to clinicaltrials.gov, this medical research is still recruiting participants since it was first published on June 9th 2015 and last updated on January 24th 2023. The trial requires 160 patients from a single location for participation."
Answered by AI
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