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Respiratory Swallow Training for Swallowing Disorders in Head and Neck Cancer

N/A
Waitlist Available
Led By Bonnie J. Martin-Harris, PhD
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
6 months post-traditional swallowing treatment with continued dysphagia
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 days, 60 days, 120 days, 240 days
Awards & highlights

Study Summary

This trial is testing a new swallowing treatment approach to improve swallowing function in Veterans with swallowing impairment following treatment for head and neck cancer.

Who is the study for?
This trial is for Veterans and non-Veterans over 21 who've had treatment for head and neck cancer, are at least 6 months post-treatment, still have trouble swallowing despite past therapy, can speak English, and pass a cognitive test. It's not for those with severe lung disease (COPD), heavy alcohol use, recent pneumonia from aspiration or allergies to contrast materials used in the study.Check my eligibility
What is being tested?
The study tests respiratory-swallow training (RST) against standard care to see if it improves eating, drinking, health outcomes and quality of life after head and neck cancer treatments. Participants will be randomly assigned to either RST or standard care groups.See study design
What are the potential side effects?
Specific side effects aren't detailed but may include discomfort during exercises or potential risks associated with swallowing assessments using contrast materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been receiving treatment for difficulty swallowing for at least 6 months, but your swallowing problem has not improved.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 days, 60 days, 120 days, 240 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 days, 60 days, 120 days, 240 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in MBSImP physiologic function metrics of the oropharyngeal swallow
Secondary outcome measures
Functional Oral Intake Scale (FOIS)
Erythrocyte Indices
Penetration Aspiration scale
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RSTExperimental Treatment1 Intervention
Respiratory Swallow Training Arm
Group II: Standard of CareActive Control1 Intervention
Standard of Care Arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Respiratory Swallow Training
2018
N/A
~40

Find a Location

Who is running the clinical trial?

Edward Hines Jr. VA HospitalFED
14 Previous Clinical Trials
1,742 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,608 Previous Clinical Trials
3,306,203 Total Patients Enrolled
Bonnie J. Martin-Harris, PhDPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL

Media Library

Respiratory Swallow Training Clinical Trial Eligibility Overview. Trial Name: NCT03377270 — N/A
Swallowing Difficulty Research Study Groups: Standard of Care, RST
Swallowing Difficulty Clinical Trial 2023: Respiratory Swallow Training Highlights & Side Effects. Trial Name: NCT03377270 — N/A
Respiratory Swallow Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03377270 — 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 individuals are taking part in this research project?

"Affirmative, according to clinicaltrials.gov this investigation is actively recruiting volunteers. It was initially posted on October 1st 2018 and underwent its latest edit on June 10th 2022. The trial aims to enrol 99 participants at a single site."

Answered by AI

Is this research endeavor currently entertaining any new participants?

"Yes, according to clinicaltrials.gov, this research is actively recruiting participants – the trial was originally advertised on October 1st 2018 and revised most recently on June 10th 2022. The study requires 99 people across a single location for participation."

Answered by AI
~6 spots leftby Apr 2025