Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 3:24 AM
Study NCT ID:
NCT04437394
Status:
COMPLETED
Last Update Posted:
2020-06-19
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D055154', 'term': 'Dysphonia'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of swallowing', 'timeFrame': '3 months', 'description': 'Quality of swallowing was assessed by Eating Assessment Tool inventory consisting in 10 questions that scores from 0 to 40. Low score is better, higher score is worse.'}, {'measure': 'Values of aspiration', 'timeFrame': '3 months', 'description': 'Aspiration was assessed by aspiration penetration scale during swallowing with flexible endoscopy. The scale consisting in 8 degree that scored from 1 to 8. Higher score is worse.'}, {'measure': 'Voice analysis', 'timeFrame': '3 months', 'description': 'Voice recordings were analyzed by PRAAT computer software. The investigator measured to shimmer, jitter and HNR voice values. The values are variation of frequency and amplitude of the sound wave. Higher value shows healthy voice for HNR parameters, lower value shows healthy voice for shimmer and jitter.'}, {'measure': 'Cervical spine situation', 'timeFrame': '3 months', 'description': 'Cervical spine was assessed with modify stoke ankylosing spondylitis spine score that scored from 0 to 3. Low score is better and high score is worse.'}, {'measure': 'Ankylosing spondylitis disease activity', 'timeFrame': '3 months', 'description': 'The investigator measured to disease activity with bath ankylosing spondylitis disease activity index consisting in 6 questions that scored from 0 to 10 and morning rigidity times. Low scores are better and high scores are worse.'}], 'secondaryOutcomes': [{'measure': 'Demographic values', 'timeFrame': '3 months', 'description': 'Demographic values were assessed as age (18-70) ,education and gender (male or female).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankylosing spondylitis, swallowing, voice'], 'conditions': ['Ankylosing Spondylitis', 'Swallowing Disorder.Other Specified', 'Voice Alteration']}, 'referencesModule': {'references': [{'pmid': '15051621', 'type': 'RESULT', 'citation': "Creemers MC, Franssen MJ, van't Hof MA, Gribnau FW, van de Putte LB, van Riel PL. Assessment of outcome in ankylosing spondylitis: an extended radiographic scoring system. Ann Rheum Dis. 2005 Jan;64(1):127-9. doi: 10.1136/ard.2004.020503. Epub 2004 Mar 29."}, {'pmid': '17906496', 'type': 'RESULT', 'citation': 'Kelly AM, Drinnan MJ, Leslie P. Assessing penetration and aspiration: how do videofluoroscopy and fiberoptic endoscopic evaluation of swallowing compare? Laryngoscope. 2007 Oct;117(10):1723-7. doi: 10.1097/MLG.0b013e318123ee6a.'}, {'pmid': '19140539', 'type': 'RESULT', 'citation': 'Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.'}, {'pmid': '34259915', 'type': 'DERIVED', 'citation': 'Ahmed EA, Atar S, Atar Y, Sari H, Anarat MEA, Salturk Z, Karaketir SG, Uyar Y, Kuru O. Evaluation of the Swallowing and Voice Functions in Ankylosing Spondylitis Patients. Dysphagia. 2022 Apr;37(2):455-462. doi: 10.1007/s00455-021-10340-1. Epub 2021 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'In this study was to determine whether changes that occurred over time had an impact on the swallowing and voice functions depend of Ankylosing spondylitis patients.', 'detailedDescription': 'This study was carried out at the University of Health Sciences Okmeydani Training and Research Hospital, Department of Otorhinolaryngology. Study was performed on 30 patients and 30 healthy subjects (Group 2) who were diagnosed with ankylosing spondylitis using modified New York criterion. The patients were asked to fill the EAT-10 and flexible endoscopic swallowing evaluation was performed. Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Ankylosing spondylitis\n* Person who accept to consent form\n\nExclusion Criteria:\n\n* Pulmoner diseases\n* Laryngeal polip or nodules\n* Underwent to larynx or esophageal surgery\n* Central nerve system diseases'}, 'identificationModule': {'nctId': 'NCT04437394', 'briefTitle': 'Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients', 'orgStudyIdInfo': {'id': '903-19/06/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Study group was performed on 30 patients who were diagnosed with ankylosing spondylitis using modified New York criterion.', 'interventionNames': ['Diagnostic Test: flexible endoscopic evaluation of swallowing', 'Diagnostic Test: The analysis of voice']}, {'label': 'Control group', 'description': 'Control group was performed on 30 participants who were healthy.', 'interventionNames': ['Diagnostic Test: flexible endoscopic evaluation of swallowing', 'Diagnostic Test: The analysis of voice']}], 'interventions': [{'name': 'flexible endoscopic evaluation of swallowing', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.', 'armGroupLabels': ['Control group', 'Study group']}, {'name': 'The analysis of voice', 'type': 'DIAGNOSTIC_TEST', 'description': 'Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Prof Dr Cemil Tascioglu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yavuz Atar, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Health Sciences, Istanbul Prof. Dr. Cemil Tascioglu City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yavuz Atar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Yavuz Atar', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}