Recruiting

Pharyngeal Exerciser

Sponsor:

Medical College of Wisconsin

Code:

NCT05708911

Conditions

Dysphagia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Pharyngeal exerciser

Study Details

Brief summary:

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.

Conditions

Dysphagia

Study ID

NCT05708911

Start date

Sep 16, 2014

Status verified date

Jan, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pharyngeal exerciser group

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

Interventions

Pharyngeal exerciser

Pharyngo-esophageal manometry during lateral fluoroscopy

Primary outcome measure

  • laryngeal excursion during swallowing [ Time Frame: During mano-fluorography procedure ]
  • hyoid excursion during swallowing [ Time Frame: During mano-fluorography procedure ]
  • upper esophageal sphincter (UES) opening during swallowing [ Time Frame: During mano-fluorography procedure ]
  • pharyngeal peak peristaltic pressure [ Time Frame: During mano-fluorography procedure ]
  • pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration [ Time Frame: During mano-fluorography procedure ]
  • pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral [ Time Frame: During mano-fluorography procedure ]
  • hypopharyngeal intrabolus pressure [ Time Frame: During mano-fluorography procedure ]
  • hypopharyngeal intrabolus duration [ Time Frame: During mano-fluorography procedure ]
  • UES nadir pressure [ Time Frame: During mano-fluorography procedure ]
  • UES relaxation time [ Time Frame: During mano-fluorography procedure ]
  • baseline UES pressure [ Time Frame: During mano-fluorography procedure ]

Central Contacts and Locations

Central contacts

Reza Shaker, MD

4149556840rshaker@mcw.edu

Mark Kern

4148053826mkern@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53086

Contacts

Reza Shaker, MD

4149556840rshaker@mcw.edu

Mark Kern

4148053826mkern@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-01-14.