What side effects are associated with this type of intervention?

Common treatments for swallowing difficulty, such as modified barium swallow studies and videofluoroscopy, are generally safe but may cause minor discomfort or a temporary sensation of fullness. Swallowing exercises, often prescribed to improve muscle function, can lead to temporary fatigue or soreness. Dietary modifications, including thickened liquids, may be unpalatable for some patients and could lead to reduced fluid intake if not managed properly. Overall, these treatments are well-tolerated with minimal side effects.

What prior FDA approvals exist?

FDA-approved treatments for swallowing difficulty (dysphagia) primarily focus on addressing the underlying causes and symptoms. Diagnostic tools such as videofluoroscopic swallow studies and fiberoptic endoscopic evaluation of swallowing are commonly used to assess dysphagia. Medications like proton pump inhibitors (PPIs) are often prescribed to manage gastroesophageal reflux disease (GERD), which can contribute to swallowing difficulties. Additionally, drugs like amifostine and pilocarpine have been approved to manage xerostomia (dry mouth), a condition that can exacerbate dysphagia, particularly in patients undergoing radiation therapy for head and neck cancers.

What other types of research exist?

Promising novel alternatives to traditional screening tests for dysphagia and aspiration risk include high-resolution manometry (HRM), which provides detailed pressure measurements of the esophagus, and functional endoscopic evaluation of swallowing (FEES), which allows direct visualization of the swallowing process. Additionally, advancements in machine learning algorithms for analyzing swallowing sounds and patterns, as well as the development of portable, non-invasive devices like acoustic pharyngometers, are emerging as potential diagnostic tools.

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Screening Methods for Swallowing Disorders

N/A

Recruiting

Led By Oliver Acosta, MD

Research Sponsored by University of Miami

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 up to 20 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying ways to check for swallowing problems in stroke patients. It focuses on people who have had a stroke because they often have trouble swallowing. The tests help doctors find out if these patients are at risk of health issues from swallowing difficulties.

Who is the study for?

This trial is for adults aged 18-80 who've had an ischemic stroke within the last month and are at Lynn Rehabilitation Center. They must understand English or Spanish, be able to consent (or have a proxy do so), and not have a history of swallowing issues or certain brain injuries.

What is being tested?

The study compares two tests for dysphagia after an ischemic stroke: one is a non-standardized clinical evaluation, and the other uses the Mann Assessment of Swallowing Ability. It aims to identify which better detects swallowing difficulties and aspiration risk.

What are the potential side effects?

Since this trial involves screening tools rather than medications, there are no direct side effects from interventions. However, discomfort during swallow evaluations may occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 20 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 20 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Deglutition Disorders

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

Group I: Non-standardized clinical swallow evaluation GroupExperimental Treatment1 Intervention

Participants in this group will receive standard of care treatment (dysphagia screening once upon admission to inpatient rehabilitation using a non-standardized clinical swallow evaluation for approximately 15 minutes).

Group II: Mann Assessment of Swallowing Ability (MASA) GroupExperimental Treatment1 Intervention

Participants in this group will receive the MASA dysphagia screening once upon admission to inpatient rehabilitation for approximately 20 minutes.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for swallowing difficulty include dietary modifications, swallowing therapy, and medical or surgical interventions. Dietary modifications involve altering food texture and consistency to make swallowing safer and easier. Swallowing therapy, often conducted by speech-language pathologists, focuses on exercises and techniques to strengthen the muscles involved in swallowing and improve coordination. Medical interventions may include medications to manage underlying conditions, while surgical options can address structural abnormalities. These treatments are crucial for dysphagia patients as they help prevent aspiration, improve nutritional intake, and enhance overall quality of life. Accurate screening tests for dysphagia and aspiration risk are essential to tailor these treatments effectively and ensure patient safety.