External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing

Dysphagia Clinical Trial

Official title:

Impact of External Pharyngeal Exerciser on Pharyngeal Phase of Swallowing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708911
• Other study ID #: PRO00022959
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2014
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: Reza Shaker, MD
• Phone: 4149556840
• Email: rshaker[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

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