Trials / Completed
CompletedNCT04130867
Rehabilitation Manometry Study
Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4 (actual)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Accepted
Summary
Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function. This proposed project will address a central hypotheses that objective swallowing measures (including (pHRM) will reveal treatment-mediated swallowing changes, will align with patient-reported outcome measures, and will be able to predict who will benefit from treatment. The investigators will follow a cohort of participants with oropharyngeal dysphagia as they undergo either pharyngeal strengthening therapy or relief of upper esophageal sphincter outlet obstruction at three time points: baseline, mid-treatment (4-6 weeks) and post-treatment (10-12 weeks). The investigators will compare participants to healthy controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | pHRM | Pharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing. |
| PROCEDURE | VFSS | Videofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement. |
Timeline
- Start date
- 2020-11-11
- Primary completion
- 2021-04-21
- Completion
- 2021-04-21
- First posted
- 2019-10-18
- Last updated
- 2025-10-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04130867. Inclusion in this directory is not an endorsement.