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Behavioural Intervention

Lingual Strengthening Exercises for Swallowing Difficulty

N/A

Recruiting

Led By Timothy M. McCulloch, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Receive a dysphagia diagnosis by a speech-language pathologist

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, and 8 weeks

Awards & highlights

Study Summary

This trial will follow a group of Veterans with dysphagia as they do oropharyngeal exercises for 8 weeks, with the goal of strengthening their oropharynx.

Who is the study for?

This trial is for Veterans who have difficulty swallowing (dysphagia) and are undergoing treatment to strengthen their throat muscles. They must be able to speak English, consent to participate, and have been diagnosed with dysphagia by a speech-language pathologist. Those allergic to barium or topical anesthetics cannot join.Check my eligibility

What is being tested?

The study tests the effectiveness of standard care exercises aimed at strengthening throat muscles in Veterans with dysphagia over 8 weeks. It compares changes in swallowing function against non-dysphagic controls using various assessments and aims to develop predictive algorithms for treatment success.See study design

What are the potential side effects?

Since this trial involves standard care exercises rather than medication, side effects may include discomfort or fatigue from the exercises themselves but no drug-related side effects are expected.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with swallowing difficulties by a speech therapist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, and 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, and 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Swallowing clinical and fluoroscopic change

pHRM pressure change

Secondary outcome measures

Patient reported outcome changes

Patient reported outcome changes, Diet change

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patient groupExperimental Treatment1 Intervention

lingual strengthening

Group II: ControlsActive Control1 Intervention

No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,304,984 Total Patients Enrolled

Timothy M. McCulloch, MDPrincipal InvestigatorWilliam S. Middleton Memorial Veterans Hospital, Madison, WI

Media Library

Standard of Care Lingual Strengthening (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04569097 — N/A

Swallowing Difficulty Research Study Groups: Controls, Patient group

Swallowing Difficulty Clinical Trial 2023: Standard of Care Lingual Strengthening Highlights & Side Effects. Trial Name: NCT04569097 — N/A

Standard of Care Lingual Strengthening (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04569097 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this clinical research?

"This clinical trial requires 200 applicants that meet the established criteria. Patients may apply at Edward Hines Jr. VA Hospital in Hines, IL or Cincinnati VA Medical Center in Ohio's largest city, Cincinnati."

Answered by AI

Is it feasible to participate in this experiment?

"This trial is in search of 200 persons with dysphagia that range from 18 to 99 years old. To be eligible, applicants must have receive a dysphagia diagnosis from a speech-language pathologist and possess an established treatment plan designed to strengthen their oropharyngeal muscles."

Answered by AI

Are individuals currently being enrolled for this research study?

"The research data stored on clinicaltrials.gov indicates that recruitment for this trial is ongoing. The study was first launched on June 28th 2021 and has since been updated to reflect the most recent changes implemented, which occurred September 2nd 2022."

Answered by AI

Are the age requirements for this study limited to those below eighty years of age?

"As per the criteria for participation, only those aged between 18 and 99 are eligible to join this medical trial. Alternatively, there are 7 trials available for children below 18 years old and 67 other studies targeting people over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

2021. "Novel Pharyngeal Metrics to Predict Dysphagia Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04569097.

All > Dysphagia