Behcet SyndromeNCT05142995
Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease
An observational study of Behcet Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of Sleep-related breathing disorders, anxiety, depression and quality of life in Behcet's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behcet Syndrome
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Clinical examination and assessment of Behçet's disease activity (International Criteria for Behçet's disease - point score system: scoring ⩾4 indicates Behçet's disease).
Who cannot join
- Patients who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of Sleep-related breathing disorders, anxiety, depression and quality of life in Behcet's disease.
Read the 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.
- Conditions
- Behcet Syndrome
- Keywords
- Behcet Syndrome, Sleep disorders, Anxiety, Quality of life
- Medical subject headings
- Behcet Syndrome, Sleep Wake Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Sep 2021
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Behcet SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Gamal Elddin Khaleel, Assiut University
- Investigators
- Waleed Gamal elddin, Phd, Principal investigator, Assiut university hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142995
- Sponsor's protocol ID
- WGEK1
- Status last verified
- Jan 2024
- First submitted
- 20 Nov 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29362466Uygunoglu 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.
PubMed 24457203International 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.
PubMed 23441863
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease
- ClinicalTrials.gov ID
- NCT05142995
- Acronym / sponsor ID
- WGEK1
- Conditions
- Behcet Syndrome
- Keywords
- Behcet Syndrome, Sleep disorders, Anxiety, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of Sleep-related breathing disorders, anxiety, depression and quality of life in Behcet's disease.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Clinical examination and assessment of Behçet's disease activity (International Criteria for Behçet's disease - point score system: scoring ⩾4 indicates Behçet's disease).
Key exclusion criteria (1 listed)
- Patients who refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence and type of sleeping disorders among Behcet's disease population
Time frame: 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 anxiety in those patients
Time frame: 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.
presence and degree of depression in those patients
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 29362466Yazici 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.
- Background: PubMed 24457203Uygunoglu 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.
- Background: PubMed 23441863International 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.
- Individual participant dataSharing planned: No
Related trials for Behcet Syndrome
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingPhase 2
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Behçet's Syndrome, Behçet's Syndrome (BS)
RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Behcet Syndrome, Intestinal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed Gamal elddin, Phd principal investigator
Assiut university hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behcet Syndrome, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence and type of sleeping disorders among Behcet's disease population (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05142995, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.