N/A
N=44
Swallowing Impairment After COVID-19 Infection
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04537650 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants With Impaired Swallowing Safety — 3; 1 Participants — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Videofluoroscopic Swallowing Study (VFSS) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Impaired Swallowing Safety |
3; 1 | <0.001 sig |
| PRIMARY Number of Participants With Impaired Swallowing Efficiency |
4; 0 | <0.001 sig |
| SECONDARY Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure |
6; 14 | — |
| SECONDARY Number of Participants With Short Laryngeal Vestibule Closure Duration |
3; 4 | — |
| SECONDARY Number of Participants With Poor Pharyngeal Constriction |
6; 6 | — |
| SECONDARY Number of Participants With Impaired LVC Integrity |
1; 0 | — |
Summary
This is an observational study, in which people recovering from COVID-19 infection will attend an outpatient clinic for a comprehensive swallowing assessment. The assessment will include a videofluoroscopy, measurement of respiratory-swallow coordination using a digital stethoscope, measures of tongue and cough strength and patient reported measures that will help us to understand the presence and impact of swallowing impairment (dysphagia) in this population.
Eligibility Criteria
Inclusion Criteria
- People who tested positive or received a presumed positive diagnosis of COVID-19 infection not earlier than March 1, 2020 and who are at least 2 weeks post positive diagnosis and the initiation of medical management of COVID-19 infection
- Adequate comprehension of English to understand the consent form and follow study instructions
Exclusion Criteria
- Age under 18 years old
- Current pregnancy
Data sourced from ClinicalTrials.gov (NCT04537650). 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.