Covid19NCT04537650
Swallowing Impairment After COVID-19 Infection
An observational study of Covid19, run by University Health Network, Toronto at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Videofluoroscopic Swallowing Study (VFSS)
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals recovering from COVID-19 infection
Who may be able to join
- 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
Who cannot join
- Age under 18 years old
- Current pregnancy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Florida
Gainesville, Florida, 32610-3006
About this study
Official title: The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Videofluoroscopic Swallowing Study (VFSS)
- Keywords
- Swallowing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videofluoroscopic Swallowing Study (VFSS)Diagnostic test
A standardized dynamic radiographic examination of oropharyngeal swallowing
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Ventilated | Participants who were diagnosed with COVID-19 prior to October, 2021 who required hospitalization in an ICU with mechanical ventilation during their illness. Receives: Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS) | |
| COVID-19 Non-Ventilated | Participants who were diagnosed with COVID-19 prior to October, 2021 who did not require mechanical ventilation during their illness. Receives: Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Impaired Swallowing Safety
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.
Measured: Videofluoroscopy session (single timepoint only)
Number of Participants With Impaired Swallowing Efficiency
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)
Measured: Videofluoroscopy session (single timepoint only)
Secondary outcomes (4)
Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure
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)
Measured: Videofluoroscopy session (single timepoint only)
Number of Participants With Short Laryngeal Vestibule Closure Duration
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)
Measured: Videofluoroscopy session (single timepoint only)
Number of Participants With Poor Pharyngeal Constriction
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)
Measured: Videofluoroscopy session (single timepoint only)
Number of Participants With Impaired LVC Integrity
Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.
Measured: Videofluoroscopy (single timepoint only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Jan 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), McMaster University, University of Florida
- Responsible party
- Sponsor
- Investigators
- Catriona M Steele, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537650
- Sponsor's protocol ID
- CAPCR 20-5477
- Other IDs
- 3R01DC011020-08S1
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2020
- Last updated
- 6 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31021676Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
PubMed 8721066Steele 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.
PubMed 37669617
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19
- ClinicalTrials.gov ID
- NCT04537650
- Acronym / sponsor ID
- CAPCR 20-5477
- Conditions
- Covid19
- Keywords
- Swallowing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), McMaster University, University of Florida
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Posted 6 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Ventilated | – | Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)Participants who were diagnosed with COVID-19 prior to October, 2021 who required hospitalization in an ICU with mechanical ventilation during their illness. |
| COVID-19 Non-Ventilated | – | Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)Participants who were diagnosed with COVID-19 prior to October, 2021 who did not require mechanical ventilation during their illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals recovering from COVID-19 infection
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Age under 18 years old
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videofluoroscopic Swallowing Study (VFSS)A standardized dynamic radiographic examination of oropharyngeal swallowing | Diagnostic test | COVID-19 Non-Ventilated, COVID-19 Ventilated |
Primary outcome
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.
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)
4 secondary outcomes
Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure
Time frame: Videofluoroscopy session (single timepoint only)
Number of Participants With Short Laryngeal Vestibule Closure Duration
Time frame: Videofluoroscopy session (single timepoint only)
Number of Participants With Poor Pharyngeal Constriction
Time frame: Videofluoroscopy session (single timepoint only)
Number of Participants With Impaired LVC Integrity
Time frame: Videofluoroscopy (single timepoint only)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31021676Steele 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.
- Background: PubMed 8721066Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
- Background: PubMed 37669617Steele 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.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catriona M Steele, PhD principal investigator
University Health Network, Toronto
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University Health Network, Toronto at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Impaired Swallowing Safety (time frame: Videofluoroscopy session (single timepoint only)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04537650, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.