External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing

Impact of External Pharyngeal Exerciser on 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.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Device: Pharyngeal exerciser

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reza Shaker, MD; Phone Number: 4149556840; Email: rshaker@mcw.edu
• Study Contact Backup: Name: Mark Kern; Phone Number: 4148053826; Email: mkern@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53086
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Reza Shaker, MD; Phone Number: 4149556840; Email: rshaker@mcw.edu
      • Contact: Mark Kern; Phone Number: 4148053826; Email: mkern@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: Pharyngeal exerciser; Pharyngo-esophageal manometry during lateral fluoroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
laryngeal excursion during swallowing	maximum laryngeal excursion from resting position measured from fluoroscopic images during swallowing	During mano-fluorography procedure
hyoid excursion during swallowing	maximum hyoid bone excursion from resting position measured from fluoroscopic images during swallowing	During mano-fluorography procedure
upper esophageal sphincter (UES) opening during swallowing	maximum UES anterior-posterior diameter measured from fluoroscopic images during swallowing	During mano-fluorography procedure
pharyngeal peak peristaltic pressure	maximum deglutitive pressure within the pharynx	During mano-fluorography procedure
pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration	manometric duration of peristaltic pressure wave in velopharynx, oropharynx and hypopharynx	During mano-fluorography procedure
pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral	space-time and length integral of pharyngeal pressures in the velopharynx, oropharynx and hypopharynx	During mano-fluorography procedure
hypopharyngeal intrabolus pressure	maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx	During mano-fluorography procedure
hypopharyngeal intrabolus duration	duration of maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx	During mano-fluorography procedure
UES nadir pressure	minimum pressure within the upper esophageal sphincter (UES) during UES deglutitive relaxation	During mano-fluorography procedure
UES relaxation time	duration pressure drops within the upper esophageal sphincter during UES deglutitive relaxation	During mano-fluorography procedure
baseline UES pressure	average UES pressure when no swallow activity is present	During mano-fluorography procedure

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Reza Shaker, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2014
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: PRO00022959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No