Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-04-22 @ 11:57 PM
Study NCT ID:
NCT05142995
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2021-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001528', 'term': 'Behcet Syndrome'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2021-11-20', 'studyFirstSubmitQcDate': '2021-11-20', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "prevalence and type of sleeping disorders among Behcet's disease population", 'timeFrame': '4 months', 'description': 'Pittsburgh Sleep Quality Index (PSQI):\n\nSelf-reported questionnaire consists of a combination of Likert-type and open-ended questions. Scores for each question range from 0 to 3. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher scores indicating more acute sleep disturbances.'}, {'measure': 'presence and degree of anxiety in those patients', 'timeFrame': '4 months', 'description': 'Hamilton Anxiety Rating Scale (HAM-A):\n\nconsists of 14 items, each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score ≤ 17 indicates mild anxiety, 18-24 mild to moderate severity, and more than 24 moderate to severe anxiety.'}, {'measure': 'presence and degree of depression in those patients', 'timeFrame': '4 months', 'description': 'Hamilton Depression Rating Scale (HAM-D):\n\nThe original HAM-D has 21 items, but scoring is based only on the first 17. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and more than 22 very severe depression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behcet Syndrome', 'Sleep disorders', 'Anxiety', 'Quality of life'], 'conditions': ['Behcet Syndrome']}, 'referencesModule': {'references': [{'pmid': '29362466', 'type': 'BACKGROUND', 'citation': 'Yazici H, Seyahi E, Hatemi G, Yazici Y. Behcet syndrome: a contemporary view. Nat Rev Rheumatol. 2018 Jan 24;14(2):119. doi: 10.1038/nrrheum.2018.3.'}, {'pmid': '24457203', 'type': 'BACKGROUND', 'citation': 'Uygunoglu U, Benbir G, Saip S, Kaynak H, Siva A. A polysomnographic and clinical study of sleep disorders in patients with Behcet and neuro-Behcet syndrome. Eur Neurol. 2014;71(3-4):115-9. doi: 10.1159/000355277. Epub 2014 Jan 21.'}, {'pmid': '23441863', 'type': 'BACKGROUND', 'citation': "International Team for the Revision of the International Criteria for Behcet's Disease (ITR-ICBD). The International Criteria for Behcet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47. doi: 10.1111/jdv.12107. Epub 2013 Feb 26."}]}, 'descriptionModule': {'briefSummary': "Assessment of Sleep-related breathing disorders, anxiety, depression and quality of life in Behcet's disease.", 'detailedDescription': "Behçet's disease (BD) was first described by Turkish dermatologist Hulusi Behçet in 1937 as a triad of recurrent oral aphthae, genital ulcerations and relapsing uveitis. Behçet disease (BD) is an inflammatory vasculopathy with multisystemic involvement. The clinical course usually follows a relapsing-remitting course with heterogeneous clinical manifestations.\n\nThe complexity of signs and symptoms in BD can disturb an individual's lifestyle by causing limitation in activity. As a result, numerous psychological problems may arise. Furthermore, it was shown in some studies that in patients with BD with fatigue, there was a significant association with impaired quality of life.\n\nSome studies reported the sleep quality in Behcet disease is very poor, and restless legs syndrome, fatigue, depression, anxiety, and activity of Behcet disease could affect to the quality of life.\n\nHowever, to date, there have been limited studies regarding sleep quality, quality of life, and depression in Behcet disease patients. Extrapolating that Behcet disease, a kind of Vasculitis, also affects the sleep quality, it is considered a meaningful study to compare and analyze the relationship between disease activity and sleep quality, quality of life, and depression in Egyptian population of Behcet disease patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Behçet's disease (BD) patients presented with a triad of recurrent oral aphthae, genital ulcerations and relapsing uveitis. Behçet disease (BD) is an inflammatory vasculopathy with multisystemic involvement. The clinical course usually follows a relapsing-remitting course with heterogeneous clinical manifestations. diagnosis made by International Criteria for Behçet's disease - point score system: scoring ⩾4 indicates Behçet's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical examination and assessment of Behçet's disease activity (International Criteria for Behçet's disease - point score system: scoring ⩾4 indicates Behçet's disease).\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study."}, 'identificationModule': {'nctId': 'NCT05142995', 'briefTitle': "Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': "Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease", 'orgStudyIdInfo': {'id': 'WGEK1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Behcet disease', 'description': 'Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale SF36 questionnaire Epworth sleepiness scale Pittsburgh sleep quality index'}, {'label': 'control', 'description': 'Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale SF36 questionnaire Epworth sleepiness scale Pittsburgh sleep quality index'}]}, 'contactsLocationsModule': {'locations': [{'zip': '711111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Waleed Gamal elddin, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut university hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Chest diseases and tuberculosis', 'investigatorFullName': 'Waleed Gamal Elddin Khaleel', 'investigatorAffiliation': 'Assiut University'}}}}