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

NCT05142995 | Completed DMC

• 1 other identifier: WGEK1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Behcet Syndrome

Keywords

Behcet Syndrome; Sleep disorders; Anxiety; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Patients who refuse to participate in the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 711111, Egypt

Location

Related Publications (3)

• 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: 29362466 BACKGROUND

• 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: 24457203 BACKGROUND

• 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.

  PMID: 23441863 BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome; Sleep Wake Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Waleed Gamal elddin, Phd

  Assiut university hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Chest diseases and tuberculosis

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 3, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)