N/A
N=227
Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
Dysphagia · Swallowing Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04569097 ↗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
| Outcome | Result | p-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
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.