Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study) (DYADS)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Covid19; Dysphagia; SARS-CoV-2 Infection; SARS (Severe Acute Respiratory Syndrome); Dysphonia; Voice Disorders; Swallowing Disorder; SARS Pneumonia; Subglottic Stenosis
• Intervention / Treatment: Diagnostic test: Fibreoptic Endoscopic Evaluation of Swallowing (FEES); Diagnostic test: Videofluoroscopy; Other: Dysphagia Handicap Index (DHI); Other: Voice Symptom Scale (VoiSS)

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients identified with dysphagia and dysphonia secondary to COVID19 infection. Specifically severely unwell patients and post-extubation patients.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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).	t = day 0, 1 month and 9 months

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 10, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Respiration Disorders; Esophageal Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Pharyngeal Diseases; Laryngeal Diseases; COVID-19; Infections; Deglutition Disorders; Severe Acute Respiratory Syndrome; Voice Disorders; Dysphonia; Hoarseness
• Other Study ID Numbers: 20/NW/0333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No