NCT05708911 · Medical College of Wisconsin
External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing
What this study is about
This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.
View original scientific description
This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.
Interventions
DEVICE
Pharyngeal exerciser
Pharyngo-esophageal manometry during lateral fluoroscopy
Primary outcome measures
laryngeal excursion during swallowing
Time frame: During mano-fluorography procedure
maximum laryngeal excursion from resting position measured from fluoroscopic images during swallowing
hyoid excursion during swallowing
Time frame: During mano-fluorography procedure
maximum hyoid bone excursion from resting position measured from fluoroscopic images during swallowing
upper esophageal sphincter (UES) opening during swallowing
Time frame: During mano-fluorography procedure
maximum UES anterior-posterior diameter measured from fluoroscopic images during swallowing
pharyngeal peak peristaltic pressure
Time frame: During mano-fluorography procedure
maximum deglutitive pressure within the pharynx
pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration
Time frame: During mano-fluorography procedure
manometric duration of peristaltic pressure wave in velopharynx, oropharynx and hypopharynx
pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral
Time frame: During mano-fluorography procedure
space-time and length integral of pharyngeal pressures in the velopharynx, oropharynx and hypopharynx
hypopharyngeal intrabolus pressure
Time frame: During mano-fluorography procedure
maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx
hypopharyngeal intrabolus duration
Time frame: During mano-fluorography procedure
duration of maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx
UES nadir pressure
Time frame: During mano-fluorography procedure
minimum pressure within the upper esophageal sphincter (UES) during UES deglutitive relaxation
UES relaxation time
Time frame: During mano-fluorography procedure
duration pressure drops within the upper esophageal sphincter during UES deglutitive relaxation
baseline UES pressure
Time frame: During mano-fluorography procedure
average UES pressure when no swallow activity is present
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 14, 2026 · Source of record for eligibility and locations