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Behavioural Intervention
Swallow Muscle Exercises for Swallowing Disorders
N/A
Recruiting
Led By Reza Shaker
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, during deglutitive restriction of the larynx
Awards & highlights
Study Summary
This trial will study how swallowing affects the muscles in the throat for better understanding of how it works.
Who is the study for?
This trial is for adults aged 18 to 90 with difficulty swallowing (dysphagia) but normal esophageal muscle function tests. It's not for those under 18, recent head and neck cancer patients, people allergic to lidocaine or barium, pregnant or lactating women, medically unstable individuals, those unable to use a swallow muscle exerciser even with help, cognitively impaired persons, or patients with certain muscle and neuromuscular diseases.Check my eligibility
What is being tested?
The study is testing how the muscles in the throat affect swallowing by using special imaging techniques before and after six weeks of exercises designed to strengthen these muscles. Participants will undergo assessments with and without restricting throat movements.See study design
What are the potential side effects?
Potential side effects may include discomfort from the laryngeal restriction procedure or from using the swallow muscle exercising device. Allergic reactions could occur in participants sensitive to materials used during assessments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after six weeks exerciser regimen, during deglutitive restriction of the larynx
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after six weeks exerciser regimen, during deglutitive restriction of the larynx
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
UES anterior-posterior maximum diameter during swallows
hypopharyngeal intra-bolus
maximum excursion of the hyo-laryngeal complex
+3 moreTrial Design
3Treatment groups
Active Control
Group I: Striated esophagus deglutitive motor function healthy adultsActive Control2 Interventions
Testing of manometric, impedance and biomechanical measurements during swallowing in healthy volunteer adult subjects.
Group II: Striated esophagus deglutitive motor function in patients with ineffective esophageal motilityActive Control2 Interventions
Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with ineffective esophageal motility.
Group III: Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometryActive Control2 Interventions
Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with symptoms of dysphagia but "normal" esophageal manometry by the Chicago Classification criteria.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
613 Previous Clinical Trials
1,162,282 Total Patients Enrolled
Reza ShakerPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
350 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I had surgery for head or neck cancer less than a month ago or chemo radiation less than 3 months ago.I have a condition affecting my muscle and nerve connection.I have a muscle disease, such as muscular dystrophy.I am between 18 and 90 years old and in good health.I have swallowing difficulties but my esophagus muscle test results are normal.I cannot use the exerciser by myself or with someone's help.I have difficulty thinking or making decisions.
Research Study Groups:
This trial has the following groups:- Group 1: Striated esophagus deglutitive motor function healthy adults
- Group 2: Striated esophagus deglutitive motor function in patients with ineffective esophageal motility
- Group 3: Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometry
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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