DysphagiaDYADSNCT04584658
Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
An observational study of Dysphagia and Dysphonia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dysphagia, Dysphonia, Subglottic Stenosis
- What is being tested?
- Fibreoptic Endoscopic Evaluation of Swallowing (FEES), Videofluoroscopy and Dysphagia Handicap Index (DHI)
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2020to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients identified with dysphagia and dysphonia secondary to COVID19 infection. Specifically severely unwell patients and post-extubation patients.
Who may be able to join
- Patients who have been diagnosed with a positive SARS CoV-2 test.
- Patients who have been diagnosed with dysphonia and/or dysphagia following COVID 19 treatment.
- Patients who require investigation and management for dysphonia and/or dysphagia following COVID 19 treatment.
- Adult patients aged 18 years - 85 years.
- Patients that meet threshold for referral to the joint MDT clinic following screening
Who cannot join
- Patients who cannot undertake the assessment for dysphonia and/or dysphagia.
- Patients who are being managed with palliative intent.
- Patients with pre-existing dysphonia and/or dysphagia not previously responding to therapy (pre-existing prior to COVID-19 diagnosis).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
About this study
Official title: Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.
This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.
- Conditions
- Dysphagia, Dysphonia, Subglottic Stenosis, Voice Disorders, Swallowing Disorder, Covid19
- Being tested
- Fibreoptic Endoscopic Evaluation of Swallowing (FEES), Videofluoroscopy, Dysphagia Handicap Index (DHI), Voice Symptom Scale (VoiSS)
- Medical subject headings
- Deglutition Disorders, Dysphonia, Voice Disorders, COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibreoptic Endoscopic Evaluation of Swallowing (FEES)Diagnostic test
This is the use of endoscopy during feeding trials. The patient is fed different consistencies of food and drink while an endoscope is in place (usually passed through the nasal passage and down into the throat). The endoscope provides a bird's eye view to the transit of food through the upper aero-digestive tract. This provides information from the point of food bolus formation in the mouth to the movement of the base of the tongue; the movement of pharyngeal muscles; the deflection of the epiglottis to protect the airway including the closure of the vocal cords and the passage of food into the oesophagus. Any abnormality in these steps are noted during FEES. Liquids, thickened fluids, semi-solids and solids are some of the food textures that are tested.
VideofluoroscopyDiagnostic test
A radio opaque dye is used to label the test food and drink items offered to the patient. Following this, x-ray technology is used to create a video of the outline of the patient and the structures responsible for chewing and swallowing as they injest the test materials. The study is carried out in real time in the radiology department in conjunction with a radiographer and an SLT.
Dysphagia Handicap Index (DHI)Other
This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).
Voice Symptom Scale (VoiSS)Other
This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
Based on therapy outcome measures from FEES, VoiS
Measured: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
Secondary outcomes (7)
The severity of dysphonia and/or dysphagia over an initial 12 month period (at t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months)
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measured: t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months
The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measured: t = day 5, day 10, day 14, day 21 - For in-patients only.
Relationship between severity of dysphonia and/or dysphagia with grade of ARDS
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measured: t = day 0 and 9 months
Relationship between severity of dysphonia and/or dysphagia with length of intubation
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measured: t = day 0 and 9 months
Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Measured: t = day 0 and 9 months
Relationship between severity of dysphonia on quality of life using Voice Symptom Scale (VoiSS) questionnaire over time at day 0, 1 month and 9 months.
Questionnaire assessment: This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28
Measured: t = day 0, 1 month and 9 months.
Relationship between severity of dysphagia on quality of life using Dysphagia Handicap Index (DHI) questionnaire over time at day 0, 1 month and 9 months
Questionnaire assessment: This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).
Measured: t = day 0, 1 month and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Sep 2020
- Primary completion30 Nov 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekpemi Irune, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584658
- Sponsor's protocol ID
- 20/NW/0333
- Acronym
- DYADS
- Status last verified
- Jun 2025
- First submitted
- 10 Oct 2020
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT04584658
- Acronym / sponsor ID
- DYADS / 20/NW/0333
- Conditions
- Dysphagia, Dysphonia, Subglottic Stenosis, Voice Disorders, Swallowing Disorder, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients identified with dysphagia and dysphonia secondary to COVID19 infection. Specifically severely unwell patients and post-extubation patients.
Key inclusion criteria (5 listed)
- Patients who have been diagnosed with a positive SARS CoV-2 test.
- Patients who have been diagnosed with dysphonia and/or dysphagia following COVID 19 treatment.
- Patients who require investigation and management for dysphonia and/or dysphagia following COVID 19 treatment.
- Adult patients aged 18 years - 85 years.
- Patients that meet threshold for referral to the joint MDT clinic following screening
Key exclusion criteria (3 listed)
- Patients who cannot undertake the assessment for dysphonia and/or dysphagia.
- Patients who are being managed with palliative intent.
- Patients with pre-existing dysphonia and/or dysphagia not previously responding to therapy (pre-existing prior to COVID-19 diagnosis).
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 |
|---|---|---|
| Fibreoptic Endoscopic Evaluation of Swallowing (FEES)This is the use of endoscopy during feeding trials. The patient is fed different consistencies of food and drink while an endoscope is in place (usually passed through the nasal passage and down into the throat). The endoscope provides a bird's eye view to the transit of food through the upper aero-digestive tract. This provides information from the point of food bolus formation in the mouth to the movement of the base of the tongue; the movement of pharyngeal muscles; the deflection of the epiglottis to protect the airway including the closure of the vocal cords and the passage of food into the oesophagus. Any abnormality in these steps are noted during FEES. Liquids, thickened fluids, semi-solids and solids are some of the food textures that are tested. | Diagnostic test | – |
| VideofluoroscopyA radio opaque dye is used to label the test food and drink items offered to the patient. Following this, x-ray technology is used to create a video of the outline of the patient and the structures responsible for chewing and swallowing as they injest the test materials. The study is carried out in real time in the radiology department in conjunction with a radiographer and an SLT. | Diagnostic test | – |
| Dysphagia Handicap Index (DHI)This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem). | Other | – |
| Voice Symptom Scale (VoiSS)This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28. | Other | – |
Primary outcome
Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
Time frame: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
Based on therapy outcome measures from FEES, VoiS
7 secondary outcomes
The severity of dysphonia and/or dysphagia over an initial 12 month period (at t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months)
Time frame: t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months
The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.
Time frame: t = day 5, day 10, day 14, day 21 - For in-patients only.
Relationship between severity of dysphonia and/or dysphagia with grade of ARDS
Time frame: t = day 0 and 9 months
Relationship between severity of dysphonia and/or dysphagia with length of intubation
Time frame: t = day 0 and 9 months
Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation
Time frame: t = day 0 and 9 months
Relationship between severity of dysphonia on quality of life using Voice Symptom Scale (VoiSS) questionnaire over time at day 0, 1 month and 9 months.
Time frame: t = day 0, 1 month and 9 months.
Relationship between severity of dysphagia on quality of life using Dysphagia Handicap Index (DHI) questionnaire over time at day 0, 1 month and 9 months
Time frame: t = day 0, 1 month and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia and Dysphonia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 3 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation). (time frame: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.