What side effects are associated with this type of intervention?

Common treatments for oropharyngeal dysphagia, such as behavioral interventions and swallowing exercises, generally have minimal side effects but may include temporary discomfort or fatigue during therapy sessions. More invasive treatments, like surgical interventions, can lead to complications such as infection, pain, and prolonged recovery times. Pharmacologic treatments may cause side effects like dry mouth, dizziness, or gastrointestinal issues. The Swallowing Training During Expiration trial aims to improve swallowing safety and efficiency with minimal side effects by focusing on non-invasive, respiratory-synchronized swallowing exercises.

What prior FDA approvals exist?

There is limited information available on FDA-approved treatments specifically targeting the synchronization of swallowing with the respiratory phase for Oropharyngeal Dysphagia. Most current treatments focus on dietary modifications, swallowing exercises, and pharmacologic interventions to manage symptoms. The novel approach of training swallowing initiation during the expiratory phase of respiration, as studied in the trial, represents an innovative therapeutic strategy that is not yet widely reflected in existing FDA-approved treatments.

What other types of research exist?

Promising novel alternatives to Swallowing Training During Expiration for Oropharyngeal Dysphagia patients include: 1) Pharyngeal Electrical Stimulation (PES), which uses electrical impulses to stimulate the pharyngeal muscles and improve swallowing function. 2) Transcranial Magnetic Stimulation (TMS), a non-invasive method that stimulates brain regions involved in swallowing. 3) Neuromuscular Electrical Stimulation (NMES), which applies electrical currents to strengthen the muscles involved in swallowing. 4) Use of advanced biofeedback techniques, such as surface electromyography (sEMG) biofeedback, to provide real-time visual feedback during swallowing exercises. These alternatives have shown potential in clinical studies and may offer effective treatment options for dysphagia patients in 2024.

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Swallowing Initiation Training for Head and Neck Cancer-Related Swallowing Disorders

N/A

Recruiting

Led By Bonnie Martin-Harris, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Penetration Aspiration Scale (PAS) score ≥3 or impairment on at least one MBSImP OI score (laryngeal vestibular closure ≥1, tongue base retraction ≥2, or pharyngeal residue ≥2) on at least one swallow during lateral view of MBSS

Diagnosis of primary head and neck cancer

Must not have

Persistent or recurrent cancer at the time of enrollment

Diagnosis of neurological disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.

Summary

This trial tests a new method that teaches head and neck cancer survivors to swallow while exhaling. This approach aims to make swallowing safer and more efficient for those who have trouble swallowing after their cancer treatment.

Who is the study for?

This trial is for English-speaking adults who've had head and neck cancer, are three months post-treatment, can swallow some liquids, and have a certain level of swallowing difficulty. They must pass a cognitive test and not have severe lung disease or allergies to materials used in the study. Pregnant individuals or those with recurrent cancer, drug abuse history, neurological disorders, feeding tubes, or tracheostomy tubes cannot participate.

What is being tested?

The study tests a new therapy that trains patients to initiate swallowing during the expiratory phase (breathing out) to improve safety and efficiency in swallowing. Participants will undergo Respiratory-Swallow Phase Training combined with regular swallow practice.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from wearing sensors for long periods or reactions related to practicing new swallowing techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have swallowing difficulties confirmed by a specific test.

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I have been diagnosed with cancer in my head or neck.

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I can swallow liquid without needing special techniques.

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My lung function is not severely impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has come back or hasn't gone away.

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I have been diagnosed with a neurological disorder.

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I have had aspiration pneumonia in the last year.

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I cannot take liquid medicine by myself.

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I struggle to swallow liquids without using special techniques.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Penetration-Aspiration Scale scores

Change in frequency (%) of swallows initiated during expiration

Secondary study objectives

Change in Modified Barium Swallow Impairment Profile (MBSImP) scores

Change in Normalized Residue Ratio Scale scores

Other study objectives

Change in M.D. Anderson Dysphagia Inventory (MDADI) scores

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Respiratory-Swallow Phase TrainingExperimental Treatment1 Intervention

Participants will be trained to initiate swallowing during expiration.

Group II: Swallow PracticePlacebo Group1 Intervention

Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).

0 / 9Eligibility criteria met

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 oropharyngeal dysphagia include oral motor exercises, pharmacologic therapy, and innovative techniques like swallowing training during expiration. Oral motor exercises aim to strengthen the muscles involved in swallowing, improving coordination and efficiency. Pharmacologic therapies, such as anticholinergic agents, reduce saliva production to manage symptoms like drooling. The swallowing training during expiration technique focuses on synchronizing swallowing with the expiratory phase of respiration, which enhances swallowing safety and efficiency by reducing the risk of aspiration. These mechanisms are crucial for patients with oropharyngeal dysphagia as they directly address the muscle coordination and timing issues that underlie their swallowing difficulties, thereby improving their quality of life and reducing the risk of complications such as aspiration pneumonia.

Interventions for oropharyngeal dysphagia in children with neurological impairment.