CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 227 enrolled
Drug / intervention
standard of care lingual strengtheningother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04569097
NCT04569097N/ACompleted

Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry

VA Office of Research and Development·interventional·Posted Sep 29, 2020·Updated May 11, 2026

In Brief

A clinical study evaluating standard of care lingual strengthening for Dysphagia and Swallowing Disorders. Completed, enrolled 227 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 29, 2020
Enrollment StartJun 28, 2021
Primary CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.8 years ago

Interventions

standard of care lingual strengtheningother

standard or care lingual strengthening approaches with outcome measured with novel pressure metrics