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NCT Number: NCT05708911

External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study.
  • The participant's neck's physical dimensions and the device's physical dimensions will be measured and recorded. A physical examination including carotid artery auscultation will be performed.
  • After the application of local lidocaine, the high-resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the entire pharynx from the nasopharynx to the proximal esophagus. In this position, manometry recording of the entire pharynx will be possible.
  • The pharyngeal exerciser will be placed around the neck overlying the larynx. The device will be in contact with the skin without any underlying pressure using the Velcro fastening in the back of the neck.
  • Patients will be sitting in an upright position and acclimatized for 10 minutes before proceeding.
  • Each subject will perform the following swallows:
  • Dry swallows x 5 times.

5 ml and 10 ml- of water swallows at room temperature x 5 times each.

5 ml and 10 ml- mashed potato swallowed at room temperature x 5 times each.

  • The sequence of the swallow types will be randomized. The swallow will be performed under device pressure of zero, 20, 30, 40 and 60 mm Hg in a randomized fashion. Each swallow type will be repeated 5 times with 30-second intervals in between.
  • The externally applied pressure will be measured by means of the pressure gauge included in the device
  • All the subjects will be given the option to participate in the concurrent videofluoroscopic examination along with pharyngeal manometry
  • The fluoroscopy machine will be turned "on" for 5 seconds only during the swallowing. The rest of the time fluoroscopy machine will be turned off.
  • These subjects undergoing concurrent fluoroscopy and manometry will perform the following swallows at zero, 20, and 40 mm Hg of device pressure:

Dry swallows x 3 times.

5 ml and 10 ml of water mixed barium swallow at room temperature x 3 times each.

5 ml- mashed potatoes mixed with barium at room temperature x 3 times.

The participant will also be instructed to resume their regular diet and activity.

All the tracings and video recordings will be analyzed by two individuals in a blinded fashion.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharyngeal exerciser

Device

Pharyngo-esophageal manometry during lateral fluoroscopy

Primary outcomes

  1. laryngeal excursion during swallowing

    Time frame: During mano-fluorography procedure

    maximum laryngeal excursion from resting position measured from fluoroscopic images during swallowing

  2. hyoid excursion during swallowing

    Time frame: During mano-fluorography procedure

    maximum hyoid bone excursion from resting position measured from fluoroscopic images during swallowing

  3. upper esophageal sphincter (UES) opening during swallowing

    Time frame: During mano-fluorography procedure

    maximum UES anterior-posterior diameter measured from fluoroscopic images during swallowing

  4. pharyngeal peak peristaltic pressure

    Time frame: During mano-fluorography procedure

    maximum deglutitive pressure within the pharynx

  5. pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration

    Time frame: During mano-fluorography procedure

    manometric duration of peristaltic pressure wave in velopharynx, oropharynx and hypopharynx

  6. 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

  7. 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

  8. 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

  9. UES nadir pressure

    Time frame: During mano-fluorography procedure

    minimum pressure within the upper esophageal sphincter (UES) during UES deglutitive relaxation

  10. UES relaxation time

    Time frame: During mano-fluorography procedure

    duration pressure drops within the upper esophageal sphincter during UES deglutitive relaxation

  11. baseline UES pressure

    Time frame: During mano-fluorography procedure

    average UES pressure when no swallow activity is present

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Kern

CONTACT

[email protected]

4148053826

Reza Shaker, MD

CONTACT

[email protected]

4149556840

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Impact of External Pharyngeal Exerciser on Pharyngeal Phase of Swallowing

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Feb 1, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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