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

NCT ID: NCT04584658

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2023-01-30

Brief Summary

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; SARS (Severe Acute Respiratory Syndrome); SARS Pneumonia; Quality of Life; SARS-CoV-2 Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Videofluoroscopy

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.

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Ekpemi Irune

Consultant Otolaryngology, Head & Neck Surgeon.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Countries

United Kingdom

Other Identifiers

20/NW/0333

Identifier Type: -

Identifier Source: org_study_id