Recruiting

External Pharyngeal Exerciser

Sponsor:

University of Southern California

Code:

NCT05267314

Conditions

Pharyngeal Dysphagia

Dysphagia

Oral Pharyngeal Dysphagia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

pharyngeal exerciser + standard therapy

Study Details

Brief 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.

Conditions

Pharyngeal Dysphagia

Dysphagia

Oral Pharyngeal Dysphagia

Study ID

NCT05267314

Start date

Dec 7, 2021

Status verified date

Feb, 2022

Completion date

Dec 6, 2022

Anticipated

Primary completion date

Dec 6, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: standard therapy

standard therapy

experimental: exerciser and standard therapy

exerciser and standard therapy

Interventions

pharyngeal exerciser + standard therapy

Use of Pharyngeal exerciser

Primary outcome measure

  • Determine the number of adverse events associated with EPE [ Time Frame: 1 year ]
  • Determine efficacy as assessed by validated pharyngeal dysphagia questionnaire EAT-10 [ Time Frame: 1 year ]
  • Determine efficacy: effect of EPE on swallowing via effects on pyriform sinus and vallecular residue height and width [ Time Frame: 1 year ]
  • 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) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Associate Professor of Medicine

3234422084ashaker@usc.edu

Anisa Associate Professor of Medicine

3234422084ashaker@usc.edu

Locations

Anisa Shaker

Recruiting

Los Angeles, California, United States, 90089-1016

Contacts

Anisa Shaker

323-442-2084ashaker@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Mar 4, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2022-03-04.