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Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
NCT04569097 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER standard of care lingual strengthening
Study Locations (3)
Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines
Ohio
- Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati
Wisconsin
- William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2025-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04569097
The ClinicalTrials.gov registry entry for NCT04569097 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Dysphagia appearing as the primary indexed condition, and to 1 intervention — of which standard of care lingual strengthening is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04569097 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Illinois, Ohio, Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04569097 about?
NCT04569097 is a clinical study titled "Novel Pharyngeal Metrics to Predict Dysphagia Outcomes". 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 initiatio...
What is the current status of trial NCT04569097?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 222 participants. The study started on 2021-06-28. Estimated completion is 2025-09-30.
What conditions does trial NCT04569097 study?
This clinical trial studies the following conditions: Dysphagia, Swallowing Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04569097?
The interventions under investigation include: standard of care lingual strengthening (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04569097?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04569097 being conducted?
This trial has 3 study locations across Illinois, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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