NCT05708911

External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing

Impact of External Pharyngeal Exerciser on Pharyngeal Phase of Swallowing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

1. All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study. 2. 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. 3. 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. 4. 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. 5. Patients will be sitting in an upright position and acclimatized for 10 minutes before proceeding. 6. Each subject will perform the following swallows: 7. 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. 8\. 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. 9\. The externally applied pressure will be measured by means of the pressure gauge included in the device 10\. All the subjects will be given the option to participate in the concurrent videofluoroscopic examination along with pharyngeal manometry 11\. 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. 12\. 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.

Conditions

• Dysphagia

Interventions

Type	Name	Description
DEVICE	Pharyngeal exerciser	Pharyngo-esophageal manometry during lateral fluoroscopy

Timeline

• Start date: 2014-09-16
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2023-02-01
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study