Assessing the effects of a pharyngeal exerciser on swallowing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how a pharyngeal exerciser affects the pressure in the throat during swallowing in healthy young and elderly individuals. Participants will undergo a series of swallowing tests with varying pressures applied by the device to measure the impact on pharyngeal muscle workload. The study involves precise measurements and recordings using high-resolution manometry to capture the swallowing dynamics. Each participant will perform multiple swallow types under different pressure conditions to assess the exerciser's effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Healthy volunteers must be at least 18 years of age or older.

Exclusion Criteria:

* Subjects with cervical spine disorders.
* Subjects with neurological disorders like dementia, cerebrovascular diseases other than Parkinson's Disease
* Subjects with carotid artery bruit or carotid vascular disorders.
* Subjects suffering from muscle diseases like muscular dystrophies, myopathies.
* Subjects with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders.
* Subjects with any current esophageal symptoms like heartburn, dysphagia, chest pain or regurgitation.
* Subjects cannot have previous head or neck surgery or radiation.
* Subjects unable to tolerate nasal intubation.
* Subjects with significant bleeding disorders for whom nasal intubation has been deemed contraindicated.
* Subjects with a known upper airway or esophageal obstruction preventing the passage of the manometry probe.
* Subjects with autonomic dysfunction.
* Subjects having a history of allergy to lidocaine and barium.
* Subjects who are pregnant or lactating.
* Subjects who have advanced medical disorders (e.g.: chronic obstructive pulmonary disease (COPD), congestive heart failure, cirrhosis, cancer, chronic renal failure, etc.).
* Subjects who are medically unstable.

Where it's running

• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Reza Shaker, MD — Medical College of Wisconsin
• Study coordinator: Reza Shaker, MD
• Email: rshaker@mcw.edu
• Phone: 4149556840

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.