Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04569097
NA

Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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

Interventions

OTHER

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