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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreSecondary study objectives
Physiologic change in swallow performance identified on routine Modified barium swallow
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,615 Total Patients Enrolled
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