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Completed

NCT Number: NCT04537650

Swallowing Impairment After COVID-19 Infection

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster University, Hamilton, Ontario, Canada

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About this study

The recent spread of COVID-19 has led to an international pandemic, with >3 million confirmed cases to date worldwide, of which 1 million confirmed cases and >50,000 deaths have been reported in the USA. Infected individuals commonly experience severe respiratory difficulties and pneumonia, leading to hospital admission and the need for intensive care and mechanical ventilation. Emerging evidence suggests that impaired taste and smell may be early markers of the disease, and that in severe cases, there may be neurological damage in in the medulla, an important brainstem control site for both respiration and swallowing. Given the overlapping neuroanatomical regulation of breathing and swallowing, the investigators hypothesize that dysphagia (swallowing impairment) will be common in People recovering from COVID-19 (PrC-19) and associated with poorer outcomes.

The investigators will offer comprehensive swallowing assessments to PrC-19 after initial recovery and a confirmed negative test for continuing COVID-19 infection. Study sites will be located in the Toronto area (PI Steele); the Hamilton-Niagara region to the west of Toronto (Co-I Namasivayam-MacDonald) and in Gainesville, Florida (Co-I Plowman). The assessments will include the collection of case history information, videofluoroscopy (i.e., a dynamic swallowing x-ray), use of a digital stethoscope to measure respiratory-swallow coordination, measures of other risk factors for dysphagia (e.g. bulbar muscle strength) and patient-reported outcomes. Detailed analyses of the videofluoroscopy swallowing studies (i.e. dynamic x-rays) will identify specific measures of swallowing that fall outside the range of normal variation based on comparison to healthy reference values established through the PI's NIH-funded research program exploring swallowing physiology on liquids of different consistencies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videofluoroscopic swallowing study (VFSS)

Diagnostic Test

A standardized dynamic radiographic examination of oropharyngeal swallowing

Primary outcomes

  1. Number of Participants With Impaired Swallowing Safety

    Time frame: Videofluoroscopy session (single timepoint only)

    Frequency of participants demonstrating airway invasion on thin liquids, defined as Penetration-Aspiration Scale score of 3 and higher (Rosenbek et al., 1996). Higher scores indicate worse function.

  2. Number of Participants With Impaired Swallowing Efficiency

    Time frame: Videofluoroscopy session (single timepoint only)

    Frequency of participants demonstrating pharyngeal residue on extremely thick liquids measured to fill more than 1.5% of an anatomical reference scalar [%(C2-4)squared] (Steele et al., 2019)

Secondary outcomes

  1. Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure

    Time frame: Videofluoroscopy session (single timepoint only)

    Frequency of participants displaying prolonged time to airway closure (i.e. Laryngeal Vestibule Closure) on thin liquids, defined as values falling above the healthy reference 75th percentile (Steele et al., 2023)

  2. Number of Participants With Short Laryngeal Vestibule Closure Duration

    Time frame: Videofluoroscopy session (single timepoint only)

    Frequency of participants displaying short airway closure (i.e. laryngeal vestibule closure) on thin liquids, defined as a duration below the healthy reference 25th percentile (Steele et al., 2023)

  3. Number of Participants With Poor Pharyngeal Constriction

    Time frame: Videofluoroscopy session (single timepoint only)

    Frequency of participants displaying poor pharyngeal constriction on extremely thick liquids, defined as pharyngeal area above the 75th percentile healthy reference value on the frame of maximum constriction (Steele et al., 2023)

  4. Number of Participants With Impaired LVC Integrity

    Time frame: Videofluoroscopy (single timepoint only)

    Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • McMaster University
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • University of Florida

Registry information

Official study title

The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2020
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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