NCT04584658

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

Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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	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.
OTHER	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.

Timeline

• Start date: 2020-09-15
• Primary completion: 2022-11-30
• Completion: 2023-01-30
• First posted: 2020-10-14
• Last updated: 2025-06-29

Locations

1 site across 1 country: United Kingdom