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N/A N=227 Single-blind Diagnostic

Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

Dysphagia · Swallowing Disorders

Enrolled (actual)
227
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: pHRM Pressure Change (Pharyngeal) — 381; 395; 389; 402 mmHg·s·cm

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
standard of care lingual strengthening (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Sep 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
pHRM Pressure Change (Pharyngeal)
381; 395; 389; 402
PRIMARY
pHRM Pressure Change (Mesopharyngeal)
192; 185; 200; 191
PRIMARY
Swallowing Clinical and Fluoroscopic Change (MBSImP)
10.7; 6.0; 9.2; 6.8
PRIMARY
Patient Reported Outcome Changes (SSQ)
512; 149; 377; 164
SECONDARY
Patient Reported Outcome Changes (EAT-10)
13.8; 3.8; 9.0; 4.0
SECONDARY
Patient Reported Outcome Changes, Diet Change

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.

Eligibility Criteria

Inclusion Criteria

  • Signed an informed consent form
  • Receive a dysphagia diagnosis by a speech-language pathologist
  • Must have a dysphagia treatment plan with the goal of strengthening the oropharyngeal musculature
  • English speaking

Exclusion Criteria

  • history of allergic response to barium
  • history of allergic response to topical anesthetics
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04569097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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