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RecruitingNCT05603897Updated Apr 29, 2026

Non-standardized vs. Standardized Screening for Dysphagia

An interventional study of Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool) and Non-standardized clinical swallow evaluation in Dysphagia, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University of Miami · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to compare two different screening tests for detecting dysphagia (difficulty swallowing) as well as the risk for aspiration (silent swallowing of liquids/solids into the lungs) in patients after an ischemic stroke (when a blood clot blocks or narrows an artery leading to the brain).

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Conditions studied

  • Dysphagia

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Keywords

  • difficulty swallowing
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults ≥ 18 years old
  • Patients admitted to Lynn Rehabilitation Center with an admitting diagnosis consistent with acute ischemic stroke within the past 1 month
  • Patients able to provide informed, written consent. If patients are not cognitively able to give informed consent, then consent will be obtained from patient proxy in person or over the phone
  • Able to read and comprehend verbal instruction in English and/or Spanish

Exclusion criteria

Exclusion Criteria:

  • Adults > 80 years old
  • Pregnant women
  • Prisoners
  • Those with a prior history of dysphagia
  • Those with any diagnoses that include acute intracranial hemorrhage, subdural hematoma, subarachnoid hemorrhage, traumatic brain injury
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Mann Assessment of Swallowing Ability (MASA) Group

    Participants in this group will receive the MASA dysphagia screening once upon admission to inpatient rehabilitation for approximately 20 minutes.

    Other: Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)

  • Other
    Non-standardized clinical swallow evaluation Group

    Participants in this group will receive standard of care treatment (dysphagia screening once upon admission to inpatient rehabilitation using a non-standardized clinical swallow evaluation for approximately 15 minutes).

    Other: Non-standardized clinical swallow evaluation

Interventions

  • OtherMann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)

    Upon 1-2 days of admission to inpatient rehabilitation, the MASA will be administered for approximately 20 minutes during initial speech language pathology evaluation. The MASA will be administered at bedside as a cognitive/speech language evaluation as well as oropharyngeal function examination.

  • OtherNon-standardized clinical swallow evaluation

    Participants will receive current standard of care for dysphagia screening and treatment.

06

What researchers measure

Primary outcomes

  1. Dysphagia measured by MASA

    The MASA is a 24-item clinical test that evaluates swallowing in the order in which swallowing phases occur. Each item is quantitatively scored using either a 5-point or 10-point score at the end of which a total score out of 200 is summed up. The MASA takes approximately 15-20 minutes to perform and can then be repeated during a patient's clinical course to monitor for recovery.

    Time frame: Up to 20 minutes

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Study locations

1 of 1 sites recruiting
  • Lynn Rehabilitation Center / University of Miami
    Miami, Florida 33136, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05603897
Lead sponsor
University of Miami
Responsible party
Gemayaret Alvarez (Attending Physician, University of Miami) — Principal investigator
First posted
Nov 3, 2022
Start date
Apr 5, 2024
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Apr 29, 2026

Study contacts

Gemayaret Alvarez, MD
Contact
g.alvarez3@med.miami.edu
305-585-9420
Claudia Santesteban-bidot, M.S.
Contact
claudia.santesteban@jhsmiami.org
305-585-9449
Gemayaret Alvarez, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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