search
Back to results

External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing

Primary Purpose

Dysphagia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharyngeal exerciser
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharyngeal exerciser group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 13, 2023
Last Updated
January 24, 2023
Sponsor
Medical College of Wisconsin
search

1. Study Identification

Unique Protocol Identification Number
NCT05708911
Brief Title
External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing
Official Title
Impact of External Pharyngeal Exerciser on Pharyngeal Phase of Swallowing
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2014 (Actual)
Primary Completion Date
September 26, 2023 (Anticipated)
Study Completion Date
September 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Study of healthy subjects
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reza Shaker, MD
Phone
4149556840
Email
rshaker@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Kern
Phone
4148053826
Email
mkern@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Shaker, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53086
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reza Shaker, MD
Phone
414-955-6840
Email
rshaker@mcw.edu
First Name & Middle Initial & Last Name & Degree
Mark Kern
Phone
4148053826
Email
mkern@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing

We'll reach out to this number within 24 hrs