External Pharyngeal Exerciser for Dysphagia

Dysphagia Clinical Trial

Official title:

Impact of External Pharyngeal Exerciser on Dysphagia in Patients With Pharyngeal Weakness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05267314
• Other study ID #: HS-16-00374
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: December 6, 2022

Study information

• Verified date: February 2022
• Source: University of Southern California
• Contact: Associate Professor of Medicine
• Phone: 3234422084
• Email: ashaker[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pharyngeal muscle weakness and dysphagia is common in individuals post-stroke or with Parkinson's disease and in individuals with head/neck cancer who have undergone surgery and/or radiation therapy. Therapeutic options for these patients are limited. This pilot study is intended to assess the feasibility, safety, and efficacy of the External Pharyngeal Exerciser (EPE) on patients with pharyngeal dysphagia receiving swallow therapy. Feasibility will be assessed by patient acceptance and practice records. Safety will be compared between groups to test whether there is an increased risk of the EPE versus standard therapy.

Description:

Pharyngeal dysphagia is incredibly common in individuals who suffer from neurological disorders such as stroke or Parkinson's disease and in individuals with head/neck cancer who have undergone surgery and/or radiation therapy. The pharyngeal muscles in these patients are weak. Other than standard patient-driven swallow therapy, the therapeutic options for these patients are limited. Response to standard patient-drive therapy is variable and dependent on a variety of factors including the muscles most affected by the underlying disorder and patient motivation. This pilot study is intended to assess the feasibility, safety, and efficacy of the External Pharyngeal Exerciser (EPE) on patients with pharyngeal dysphagia receiving swallow therapy. Feasibility will be assessed by patient acceptance and practice records. Safety will be compared between groups to test whether there is an increased risk of the EPE versus standard therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pharyngeal dysphagia diagnosed with validated questionnaire and modified barium swallow. Participants must be at least 18 years of age or older.
• Pharyngeal dysphagia secondary to central neurological disorder such as Parkinson's disease or stroke
• Pharyngeal dysphagia head/neck cancer secondary to surgery/radiation
• Pharyngeal dysphagia secondary to elderly age > 65

Exclusion Criteria:

• Carotid artery bruit or carotid vascular disorders
• Muscle diseases like muscular dystrophies, myopathies
• Neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders
• Current esophageal symptoms like heartburn, dysphagia, chest pain or regurgitation
• Autonomic dysfunction
• Pregnancy or lactation
• Advanced uncontrolled medical disorders (COPD, congestive heart failure, cirrhosis, cancer, chronic renal failure, etc)
• Medically unstable

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Pharyngeal Dysphagia

Intervention

Device:
• pharyngeal exerciser + standard therapy
Use of Pharyngeal exerciser

Locations

Country	Name	City	State
United States	Anisa Shaker	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the number of adverse events associated with EPE	The aim is to determine whether there are any risks associated with the use of the EPE. There are no known risks to placing external pressure to the larynx. However, there is the possibility that the participant may experience discomfort such as rash or may not be able to tolerate the minimal pressure associated with the exerciser. The participant will be evaluated every two weeks by the study physician and reports of adverse events will be recorded. If the participant experiences difficulty in tolerating the minimal pressure, the study will be stopped.	1 year
Primary	Determine efficacy as assessed by validated pharyngeal dysphagia questionnaire EAT-10	Subjective evaluation of participant response to an External Pharyngeal Exerciser with a validated pharyngeal dysphagia questionnaire (EAT-10) administered as standard of care before and after therapy (scores 1-10, with higher scores mean worse outcome).	1 year
Primary	Determine efficacy: effect of EPE on swallowing via effects on pyriform sinus and vallecular residue height and width	To objectively define pharyngeal response to External Pharyngeal Exerciser with Modified Barium swallow before and after therapy: To determine if application of pharyngeal exerciser changes swallowing as evidenced by reduction in height and width of pyriform sinus and vallecular residue using fluoroscopy study.	1 year
Primary	Determine efficacy: effect of EPE on swallowing via effects on routinely measured markers of deglutition (penetration-aspiration scale, larynx and hyoid anterior/superior excursion; UES diameter, and pharyngeal transit time)	To objectively define pharyngeal response to External Pharyngeal Exerciser with Modified Barium swallow before and after therapy: To determine if application of pharyngeal exerciser changes deglutition as noticed by 1) change in aspiration and penetration measured by Rosenbek's penetration-aspiration scale; 2) change in anterior and superior excursion of larynx and hyoid; 3) change in AP and Lateral diameter of UES; 4) change in pharyngeal transit time.	1 year
Secondary	Physiologic change in swallow performance identified on routine Modified barium swallow	Physiologic changes in swallow performance: oral-motor strength, vocal cord adduction with various food consistencies, presence of penetration/aspiration, length of anterior and superior excursion of larynx, pharyngeal transit time, presence and width of vallecular/piriform residue. Poor anterior or superior excursion of larynx, diminished AP and lateral diameter of UES, presence of residue, penetration/aspiration suggests pharyngeal dysphagia. These measurements will be combined/aggregated to arrive at one reported value.	1 year