Systemic Lupus ErythematosusNCT05971498
Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Systemic Lupus Erythematosus Patients
An observational study of Systemic Lupus Erythematosus, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in Systemic Lupus Erythematosus (SLE) patients. The main aims are: asses anxiety, sleep, depression and quality of life in SLE patients their relation to disease activity we will compare SLE patients to healthy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Aug 2023to 1 Mar 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: SLE patients and healthy control
Who may be able to join
- Patients diagnosed with SLE according to the 2012 systemic lupus international collaborating clinics (SLICC) criteria .
Who cannot join
- Evidence of end-organ failures such as heart failure, liver cell or renal failure,
- History of psychological disorders .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Assiut university hospital
Asyut, 71515
About this study
The goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in Systemic Lupus Erythematosus (SLE) patients.
The main aims are:
- asses anxiety, sleep, depression and quality of life in SLE patients
- their relation to disease activity we will compare SLE patients to healthy subjects.
Read the detailed description
All patients will be subjected to clinical evaluation (full history and examination, laboratory evaluation (include erythrocyte sedimentation rate (ESR) measured by standard westergren method (mm/h), serum C-reactive protein (CRP), complete blood count (CBC), serum urea and creatinine, aspartate transaminase (AST), alanine transaminase (ALT), complete urine analysis for: urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria (WBCs/ high power field), 24-hour urinary protein and creatinine clearance. Immunological work up will include antinuclear antibodies (ANA) by ELISA, anti-double stranded DNA (ds-DNA) by ELISA and complement components C3 and C4 by nephelometry. Disease activity will be assessed via SLE disease activity index (SLEDAI): SLEDAI is based on the presence of 24 descriptors in nine organ systems over the preceding 30 days. Descriptors of SLEDAI are documented as present or absent. Each of the descriptors has a weighted score and the total score of SLEDAI is the sum of all 24 descriptor scores. The total score falls between 0 and 105, with higher scores representing higher disease activity.
Psychological assessment will be performed according to the following scales
- Hamilton Anxiety Rating Scale (HAM-A): It consists of 14 items and measures both psychic and somatic anxiety (physical complaints related to anxiety). 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 anxiety, , 25-30 moderate to severe anxiety and scores >30 indicate severe anxiety.
- Hamilton Depression Rating Scale: the original scale 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 > 22 very severe depression.
Sleep quality assessment was done via
- Insomnia severity index (ISI) : contains seven domains assessing sleep-onset difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning, impairment attributed to sleep problems, and distress associated with insomnia. Each item is rated on a 0-4 scale, and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
- Epworth sleepiness scale : subjects describe how often they fall asleep in certain situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10 is indicative of subjective excessive daytime sleepiness and score > 16 indicates high level of daytime sleepiness.
Pittsburgh Sleep Quality Index the first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score > 5 suggests poor sleep quality.
Assessment of Health status and quality of life via short form health survey (SF36):Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Higher scores indicate high quality of life.
- Conditions
- Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
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 |
|---|---|---|
| cases | Not described | |
| control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of insomnia in SLE patients by Insomnia severity index
insomnia severity index contains seven domains assessing sleep-onset difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning, impairment attributed to sleep problems, and distress associated with insomnia. Each item is rated on a 0-4 scale, and th e total score ranges from 0 to 28. A higher score suggests more severe insomnia
Measured: 3 MONTHS
evaluation of excessive daytime sleepiness in SLE patients by Epworth sleepiness scale
Subjects describe how often they fall asleep in certain situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10 is indicative of subjective excessive daytime sleepiness and score > 16 indicates high level of daytime sleepiness
Measured: 3 months
evaluation of anxiety in SLE patients by hamilton anxiety rating scale
It consists of 14 items and measures both psychic and somatic anxiety (physical complaints related to anxiety). 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 anxiety, , 25-30 moderate to severe anxiety and scores >30 indicate severe anxiety
Measured: 3 months
evaluation of depression in SLE patients by hamilton depression rating scale
The original scale has 21 items, but scoring is based only on the first 17 with total score ranges from 0 to 52. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and > 22 very severe depression.
Measured: 3 months
evaluation of QoL in SLE patients by short form health survey (sf36 )
Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Mean score ranges from 0 to100. High scores indicate lower disability
Measured: 3 months
evaluation of sleep quality and disturbances in SLE patients by Pittsburgh Sleep Quality Index
The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score > 5 suggests poor sleep quality
Measured: 3 months
Secondary outcomes (1)
Correlation of disease activity (SLEDAI) with Hamilton anxiety rating scale, Hamilton depression rating scale, Epworth sleepiness scale,Pittsburgh Sleep Quality Index and short form health survey sf 36
The SLEDAI consists of 24 items (nine organ systems) that are scored based on presence at the time of visit or in the preceding 10 days. The scoring is additive across items, with a possible total score range of 0 to 105 (higher scores represent greater disease activity).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start14 Aug 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Sayed Ibrahim Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971498
- Sponsor's protocol ID
- AssiutU SLE
- Status last verified
- Sep 2023
- First submitted
- 25 Jul 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT05971498
- Acronym / sponsor ID
- AssiutU SLE
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 2 Aug 2023 (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.
The goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in Systemic Lupus Erythematosus (SLE) patients.
The main aims are:
- asses anxiety, sleep, depression and quality of life in SLE patients
- their relation to disease activity we will compare SLE patients to healthy subjects.
Detailed description
All patients will be subjected to clinical evaluation (full history and examination, laboratory evaluation (include erythrocyte sedimentation rate (ESR) measured by standard westergren method (mm/h), serum C-reactive protein (CRP), complete blood count (CBC), serum urea and creatinine, aspartate transaminase (AST), alanine transaminase (ALT), complete urine analysis for: urinary casts (hyaline, granular), hematuria (RBCs/ high power field), pyuria (WBCs/ high power field), 24-hour urinary protein and creatinine clearance. Immunological work up will include antinuclear antibodies (ANA) by ELISA, anti-double stranded DNA (ds-DNA) by ELISA and complement components C3 and C4 by nephelometry. Disease activity will be assessed via SLE disease activity index (SLEDAI): SLEDAI is based on the presence of 24 descriptors in nine organ systems over the preceding 30 days. Descriptors of SLEDAI are documented as present or absent. Each of the descriptors has a weighted score and the total score of SLEDAI is the sum of all 24 descriptor scores. The total score falls between 0 and 105, with higher scores representing higher disease activity.
Psychological assessment will be performed according to the following scales
- Hamilton Anxiety Rating Scale (HAM-A): It consists of 14 items and measures both psychic and somatic anxiety (physical complaints related to anxiety). 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 anxiety, , 25-30 moderate to severe anxiety and scores >30 indicate severe anxiety.
- Hamilton Depression Rating Scale: the original scale 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 > 22 very severe depression.
Sleep quality assessment was done via
- Insomnia severity index (ISI) : contains seven domains assessing sleep-onset difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning, impairment attributed to sleep problems, and distress associated with insomnia. Each item is rated on a 0-4 scale, and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
- Epworth sleepiness scale : subjects describe how often they fall asleep in certain situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10 is indicative of subjective excessive daytime sleepiness and score > 16 indicates high level of daytime sleepiness.
Pittsburgh Sleep Quality Index the first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score > 5 suggests poor sleep quality.
Assessment of Health status and quality of life via short form health survey (SF36):Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Higher scores indicate high quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | – |
| control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- SLE patients and healthy control
Key inclusion criteria (1 listed)
- Patients diagnosed with SLE according to the 2012 systemic lupus international collaborating clinics (SLICC) criteria .
Key exclusion criteria (2 listed)
- Evidence of end-organ failures such as heart failure, liver cell or renal failure,
- History of psychological disorders .
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
Evaluation of insomnia in SLE patients by Insomnia severity index
Time frame: 3 MONTHS
insomnia severity index contains seven domains assessing sleep-onset difficulties, sleep maintenance, sleep satisfaction, effect on daily functioning, impairment attributed to sleep problems, and distress associated with insomnia. Each item is rated on a 0-4 scale, and th e total score ranges from 0 to 28. A higher score suggests more severe insomnia
evaluation of excessive daytime sleepiness in SLE patients by Epworth sleepiness scale
Time frame: 3 months
Subjects describe how often they fall asleep in certain situations on a scale of 0-3, with total scores ranging from 0 to 24. An ESS score ≥ 10 is indicative of subjective excessive daytime sleepiness and score > 16 indicates high level of daytime sleepiness
evaluation of anxiety in SLE patients by hamilton anxiety rating scale
Time frame: 3 months
It consists of 14 items and measures both psychic and somatic anxiety (physical complaints related to anxiety). 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 anxiety, , 25-30 moderate to severe anxiety and scores >30 indicate severe anxiety
evaluation of depression in SLE patients by hamilton depression rating scale
Time frame: 3 months
The original scale has 21 items, but scoring is based only on the first 17 with total score ranges from 0 to 52. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and > 22 very severe depression.
evaluation of QoL in SLE patients by short form health survey (sf36 )
Time frame: 3 months
Thirty-five of the 36 items are grouped into eight scales: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. One item assesses perception of changes in health over the last year but is not used calculate scale scores. Mean score ranges from 0 to100. High scores indicate lower disability
evaluation of sleep quality and disturbances in SLE patients by Pittsburgh Sleep Quality Index
Time frame: 3 months
The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components (sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use). The scores for each component are summed to get a total score (range 0-21). A score > 5 suggests poor sleep quality
1 secondary outcome
Correlation of disease activity (SLEDAI) with Hamilton anxiety rating scale, Hamilton depression rating scale, Epworth sleepiness scale,Pittsburgh Sleep Quality Index and short form health survey sf 36
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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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.
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 Systemic Lupus Erythematosus, 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 2 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Abdelrahman, MD,PhD (+201011212050, mahasayed@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of insomnia in SLE patients by Insomnia severity index (time frame: 3 MONTHS). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2023.