Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT04584658
Status:
COMPLETED
Last Update Posted:
2025-06-29
First Post:
2020-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D055154', 'term': 'Dysphonia'}, {'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2020-10-10', 'studyFirstSubmitQcDate': '2020-10-10', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'timeFrame': 't = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).', 'description': 'Based on therapy outcome measures from FEES, VoiS'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': 't = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months', 'description': 'Clinical assessment including outcome measures, FEES and/or Videofluoroscopy'}, {'measure': 'The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.', 'timeFrame': 't = day 5, day 10, day 14, day 21 - For in-patients only.', 'description': 'Clinical assessment including outcome measures, FEES and/or Videofluoroscopy'}, {'measure': 'Relationship between severity of dysphonia and/or dysphagia with grade of ARDS', 'timeFrame': 't = day 0 and 9 months', 'description': 'Clinical assessment including outcome measures, FEES and/or Videofluoroscopy'}, {'measure': 'Relationship between severity of dysphonia and/or dysphagia with length of intubation', 'timeFrame': 't = day 0 and 9 months', 'description': 'Clinical assessment including outcome measures, FEES and/or Videofluoroscopy'}, {'measure': 'Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation', 'timeFrame': 't = day 0 and 9 months', 'description': 'Clinical assessment including outcome measures, FEES and/or Videofluoroscopy'}, {'measure': '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.', 'timeFrame': 't = day 0, 1 month and 9 months.', 'description': "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"}, {'measure': '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', 'timeFrame': 't = day 0, 1 month and 9 months', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphagia', 'Dysphonia', 'Subglottic Stenosis', 'Voice Disorders', 'Swallowing Disorder', 'Covid19', 'SARS (Severe Acute Respiratory Syndrome)', 'SARS Pneumonia', 'Quality of Life', 'SARS-CoV-2 Infection']}, 'descriptionModule': {'briefSummary': 'This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients identified with dysphagia and dysphonia secondary to COVID19 infection. Specifically severely unwell patients and post-extubation patients.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been diagnosed with a positive SARS CoV-2 test.\n* Patients who have been diagnosed with dysphonia and/or dysphagia following COVID 19 treatment.\n* Patients who require investigation and management for dysphonia and/or dysphagia following COVID 19 treatment.\n* Adult patients aged 18 years - 85 years.\n* Patients that meet threshold for referral to the joint MDT clinic following screening\n\nExclusion Criteria:\n\n* Patients who cannot undertake the assessment for dysphonia and/or dysphagia.\n* Patients who are being managed with palliative intent.\n* Patients with pre-existing dysphonia and/or dysphagia not previously responding to therapy (pre-existing prior to COVID-19 diagnosis).'}, 'identificationModule': {'nctId': 'NCT04584658', 'acronym': 'DYADS', 'briefTitle': 'Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.', 'orgStudyIdInfo': {'id': '20/NW/0333'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fibreoptic Endoscopic Evaluation of Swallowing (FEES)', 'type': 'DIAGNOSTIC_TEST', 'description': "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."}, {'name': 'Videofluoroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': '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.'}, {'name': 'Dysphagia Handicap Index (DHI)', 'type': 'OTHER', 'description': '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).'}, {'name': 'Voice Symptom Scale (VoiSS)', 'type': 'OTHER', 'description': "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."}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Otolaryngology, Head & Neck Surgeon.', 'investigatorFullName': 'Ekpemi Irune', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}