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NCT04569097 · ClinicalTrials.gov registry record · NA
Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
A NA study of Dysphagia and Swallowing Disorders, sponsored by VA Office of Research and Development.
- Active
- Registry status
- NA
- Development phase
- 222
- Enrollment target
- 3
- Study locations
NCT04569097 is a NA study of Dysphagia and Swallowing Disorders that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 222 participants, above the 166-participant average among 35 other Dysphagia trials with a reported enrollment target (34% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT04569097, a NA study of Dysphagia and Swallowing Disorders, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 222 participants
- Enrollment target
- 3
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 166-participant average among 35 other Dysphagia trials with a reported enrollment target (34% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
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.
NCT04569097 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Illinois, Ohio, Wisconsin.
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.
What interventions are being tested in trial NCT04569097?
The interventions under investigation include: standard of care lingual strengthening (OTHER).
Who is sponsoring clinical trial NCT04569097?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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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Related
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