Behcet Syndrome Clinical Trial
Official title:
Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease
NCT number | NCT05142995 |
Other study ID # | WGEK1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2021 |
Est. completion date | March 1, 2023 |
Verified date | January 2024 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Assessment of Sleep-related breathing disorders, anxiety, depression and quality of life in Behcet's disease.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 1, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Clinical examination and assessment of Behçet's disease activity (International Criteria for Behçet's disease - point score system: scoring ?4 indicates Behçet's disease). Exclusion Criteria: - Patients who refuse to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | prevalence and type of sleeping disorders among Behcet's disease population | Pittsburgh Sleep Quality Index (PSQI):
Self-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. |
4 months | |
Primary | presence and degree of anxiety in those patients | Hamilton Anxiety Rating Scale (HAM-A):
consists 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. |
4 months | |
Primary | presence and degree of depression in those patients | Hamilton Depression Rating Scale (HAM-D):
The 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. |
4 months |
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