External Pharyngeal Exerciser for Dysphagia

Last updated: February 23, 2022
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heartburn

Treatment

N/A

Clinical Study ID

NCT05267314
HS-16-00374
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 30
Study Start date:
December 07, 2021
Estimated Completion Date:
December 06, 2022

Study 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.

Connect with a study center

  • Anisa Shaker

    Los Angeles, California 90089-1016
    United States

    Active - Recruiting

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