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NCT04130867 · ClinicalTrials.gov registry record

Rehabilitation Manometry Study

A clinical trial of Oropharyngeal Dysphagia, sponsored by University of Wisconsin, Madison.

Completed
Registry status
4
Enrollment target
1
Study location

NCT04130867: Completed study of Oropharyngeal Dysphagia, sponsored by University of Wisconsin, Madison.

NCT04130867 is a study of Oropharyngeal Dysphagia that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 4 participants, below the 110-participant average among 7 other Oropharyngeal Dysphagia trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04130867, a study of Oropharyngeal Dysphagia, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
4 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

pHRM data collected from the 250 adults undergoing dysphagia treatment and 50 healthy controls at three time points (baseline, mid-treatment, and post-treatment) will be used.

Conditions Studied

Oropharyngeal Dysphagia

Interventions

  • PROCEDURE pHRM
  • PROCEDURE VFSS

Study Locations (1)

Wisconsin

  • University of Wisconsin - Madison

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2020-11-11
Est. Completion 2021-04-21
University of Wisconsin, Madison

1,039 total trials

What the finished NCT04130867 record still lists

NCT04130867 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 110-participant average among 7 other Oropharyngeal Dysphagia trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Oropharyngeal Dysphagia appearing as the primary indexed condition, and to 2 interventions - of which pHRM is the first listed.

NCT04130867 reports a single indexed study location in Wisconsin.

Frequently Asked Questions

What is clinical trial NCT04130867 about?

NCT04130867 is a clinical study titled "Rehabilitation Manometry Study". 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) d...

What is the current status of trial NCT04130867?

This trial is currently completed. The enrollment target is 4 participants. The study started on 2020-11-11. Estimated completion is 2021-04-21.

What conditions does trial NCT04130867 study?

This clinical trial studies the following conditions: Oropharyngeal Dysphagia.

What interventions are being tested in trial NCT04130867?

The interventions under investigation include: pHRM (PROCEDURE), VFSS (PROCEDURE).

Who is sponsoring clinical trial NCT04130867?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04130867 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT04130867, the US trial registry maintained by the National Library of Medicine. NCT04130867 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.