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

• Conditions: Swallowing Disorder; SARS Pneumonia; Subglottic Stenosis; Quality of Life; Dysphagia; Covid19; SARS-CoV-2 Infection; Dysphonia; Voice Disorders; SARS (Severe Acute Respiratory Syndrome)

• Registration Number: NCT04584658
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-15
• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-10
• Study First Posted: 2020-10-14
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).	Based on therapy outcome measures from FEES, VoiS

Secondary Outcome Measures

Name	Time	Method
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)	t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation	t = day 0 and 9 months	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.	t = day 5, day 10, day 14, day 21 - For in-patients only.	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Relationship between severity of dysphonia and/or dysphagia with grade of ARDS	t = day 0 and 9 months	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Relationship between severity of dysphonia and/or dysphagia with length of intubation	t = day 0 and 9 months	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
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.	t = 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
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	t = 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).

Trial Locations

Locations (1)

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom