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Pharyngeal 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 during mano-fluorography procedure
Awards & highlights
Summary
This trial studies the effects of a pharyngeal exerciser on muscle workload during swallowing in young and elderly people.
Who is the study for?
This trial is for healthy individuals aged 18 or older who have no history of head or neck surgery, significant bleeding disorders, autonomic dysfunction, carotid vascular disorders, neuro-muscular junction disorders like myasthenia gravis, esophageal symptoms (e.g., heartburn), allergies to lidocaine and barium, severe medical conditions such as COPD or cancer, cervical spine or neurological disorders excluding Parkinson's Disease.
What is being tested?
The study is examining the impact of a pharyngeal exerciser on swallowing pressure in both young and elderly healthy volunteers. It aims to determine whether this device can increase muscle workload during the pharyngeal phase of swallowing.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from nasal intubation required for testing and possible soreness in throat muscles due to exercising them with the device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during mano-fluorography procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during mano-fluorography procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
UES nadir pressure
UES relaxation time
baseline UES pressure
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Pharyngeal exerciser groupExperimental Treatment1 Intervention
Test that application of the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing as evidenced manometrically by changes in
Pharyngeal peak pressures Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral Hypopharyngeal intrabolus pressure and duration UES nadir pressure UES relaxation time Baseline UES pressure
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
620 Previous Clinical Trials
1,172,514 Total Patients Enrolled
Reza Shaker, MDPrincipal InvestigatorMedical College of Wisconsin
3 Previous Clinical Trials
569 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition where your body's automatic functions, like heart rate and blood pressure, don't work properly.You have a problem with the blood vessels in your neck called carotid artery disorder.You have certain muscle and nerve disorders called myasthenia gravis or Eaton-Lambert syndrome.You are experiencing symptoms like heartburn, difficulty swallowing, chest pain, or food coming back up in your throat.You have had an allergic reaction to lidocaine or barium in the past.You have serious health conditions like COPD, heart failure, liver disease, cancer, or kidney failure.You have a problem with your neck that affects your cervical spine.You have a neurological condition like dementia or a type of stroke that is not Parkinson's Disease.You have muscle diseases like muscular dystrophies or myopathies.You cannot tolerate having a tube inserted through your nose.You have a blockage in your throat or esophagus that would make it difficult to insert the manometry probe.
Research Study Groups:
This trial has the following groups:- Group 1: Pharyngeal exerciser group
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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