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Behavioural Intervention

Lingual Strengthening Exercises for Swallowing Difficulty

N/A
Waitlist Available
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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Swallowing clinical and fluoroscopic change
pHRM pressure change
Secondary study objectives
Patient reported outcome changes
Patient reported outcome changes, Diet change

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: 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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,586 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
~51 spots leftby Nov 2025
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