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

Behcet Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142995
• Other study ID #: WGEK1
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Behcet Syndrome

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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

Outcome

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