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

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

Study Overview

• Status: Completed
• Conditions: Behcet Syndrome
• Intervention / Treatment: Diagnostic test: sleep study

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 711111
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Behcet disease; Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale SF36 questionnaire Epworth sleepiness scale Pittsburgh sleep quality index
control; Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale SF36 questionnaire Epworth sleepiness scale Pittsburgh sleep quality index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Waleed Gamal elddin, Phd, Assiut University Hospitals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: November 20, 2021
• First Submitted That Met QC Criteria: November 20, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Quality of life; Sleep disorders; Behcet Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Behcet Syndrome; Anxiety Disorders
• Other Study ID Numbers: WGEK1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No