Clinical trial NCT04537650: Swallowing Impairment After COVID-19 Infection
Official title: The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Swallowing
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: McMaster University
name: University of Florida
First posted: 2020-09-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals recovering from COVID-19 infection

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Number of Participants With Impaired Swallowing Safety
timeFrame: Videofluoroscopy session (single timepoint only)
measure: Number of Participants With Impaired Swallowing Efficiency
timeFrame: Videofluoroscopy session (single timepoint only)
Secondary outcomes:
measure: Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure
timeFrame: Videofluoroscopy session (single timepoint only)
measure: Number of Participants With Short Laryngeal Vestibule Closure Duration
timeFrame: Videofluoroscopy session (single timepoint only)
measure: Number of Participants With Poor Pharyngeal Constriction
timeFrame: Videofluoroscopy session (single timepoint only)
measure: Number of Participants With Impaired LVC Integrity
timeFrame: Videofluoroscopy (single timepoint only)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Catriona M Steele, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steele CM, Peladeau-Pigeon M, Barbon CAE, Guida BT, Namasivayam-MacDonald AM, Nascimento WV, Smaoui S, Tapson MS, Valenzano TJ, Waito AA, Wolkin TS. Reference Values for Healthy Swallowing Across the Range From Thin to Extremely Thick Liquids. J Speech Lang Hear Res. 2019 May 21;62(5):1338-1363. doi: 10.1044/2019_JSLHR-S-18-0448.
citation: Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
citation: Steele CM, Bayley MT, Bohn MK, Higgins V, Peladeau-Pigeon M, Kulasingam V. Reference Values for Videofluoroscopic Measures of Swallowing: An Update. J Speech Lang Hear Res. 2023 Oct 4;66(10):3804-3824. doi: 10.1044/2023_JSLHR-23-00246. Epub 2023 Sep 5.