Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

Completed · Not applicable

Conditions studied: Dysphagia, Swallowing Disorders

In brief

This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures. The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.

Key facts

Study ID

NCT04569097

Run by

VA Office of Research and Development

People needed

227

Starts

2021-06-28

Expected to finish

2024-09-30

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Signed an informed consent form
• Receive a dysphagia diagnosis by a speech-language pathologist
• Must have a dysphagia treatment plan with the goal of strengthening the oropharyngeal musculature
• English speaking

You may not qualify if…

• history of allergic response to barium
• history of allergic response to topical anesthetics

Where it is running

• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States
• William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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