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Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
Sponsor: VA Office of Research and Development
Summary
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.
Official title: Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
222
Start Date
2021-06-28
Completion Date
2025-09-30
Last Updated
2024-11-13
Healthy Volunteers
Yes
Conditions
Interventions
standard of care lingual strengthening
standard or care lingual strengthening approaches with outcome measured with novel pressure metrics
Locations (3)
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