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pharyngeal exerciser + standard therapy for Swallowing Difficulty

N/A
Waitlist Available
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing a new device called the External Pharyngeal Exerciser (EPE) to help people who have trouble swallowing due to conditions like stroke, Parkinson's disease, or head/neck cancer treatments. The device aims to strengthen throat muscles by providing resistance during swallowing exercises. The study will check if the device is safe, if patients are willing to use it, and if it works better than current treatments.

Eligible Conditions
  • Dysphagia
  • Oral Pharyngeal Dysphagia
  • Swallowing Difficulty

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine efficacy as assessed by validated pharyngeal dysphagia questionnaire EAT-10
Determine efficacy: effect of EPE on swallowing via effects on pyriform sinus and vallecular residue height and width
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)
+1 more
Secondary study objectives
Physiologic change in swallow performance identified on routine Modified barium swallow

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: exerciser and standard therapyExperimental Treatment1 Intervention
exerciser and standard therapy
Group II: standard therapyActive Control1 Intervention
standard therapy

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,451 Total Patients Enrolled
~8 spots leftby Sep 2025