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临床试验/NCT05142995
NCT05142995已完成不适用

Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
prevalence and type of sleeping disorders among Behcet's disease population

研究概览

简要总结

Assessment of Sleep-related breathing disorders, anxiety, depression and quality of life in Behcet's disease.

详细描述

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.

The 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.

Some 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.

However, 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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical examination and assessment of Behçet's disease activity (International Criteria for Behçet's disease - point score system: scoring ⩾4 indicates Behçet's disease).

排除标准

  • Patients who refuse to participate in the study.

结局指标

主要结局

prevalence and type of sleeping disorders among Behcet's disease population

时间窗: 4 months

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.

presence and degree of depression in those patients

时间窗: 4 months

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.

presence and degree of anxiety in those patients

时间窗: 4 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Waleed Gamal Elddin Khaleel

Lecturer of Chest diseases and tuberculosis

Assiut University

研究点 (1)

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