External Pharyngeal Exerciser for Dysphagia

NCT05267314 | Unknown DMC

• 1 other identifier: HS-16-00374
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Physiologic change in swallow performance identified on routine Modified barium swallow

  1 year

Study Arms (2)

standard therapy

NO INTERVENTION

standard therapy

exerciser and standard therapy

EXPERIMENTAL

exerciser and standard therapy

Device: pharyngeal exerciser + standard therapy

Interventions

pharyngeal exerciser + standard therapy DEVICE

Use of Pharyngeal exerciser

exerciser and standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Anisa Shaker

Los Angeles, California, 90089-1016, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Associate Professor of Medicine

CONTACT

3234422084; ashaker@usc.edu

Anisa Associate Professor of Medicine

CONTACT

3234422084; ashaker@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 4, 2022
• Study Start: December 7, 2021
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)