Sleep DisturbanceNCT03864809
• Sleep Disturbance Among Patients With Psoriasis and Atopy and Comparison Between Them
An observational study of Sleep Disturbance, run by Assiut University.
Trial summary
Comparison between sleep disturbance in atopy and psoriasis and control Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- sleep disturbance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to Aug 2020
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: This study involves the use of seven questionnaires to be given to subjects with psoriasis and a topic dermatites
Who may be able to join
- patients with Psoriasis and Patients with A topic dermatitis
Who cannot join
- All patient have another dermatological disease
Trial locations and contacts
No sites are listed yet.
About this study
Comparison between sleep disturbance in atopy and psoriasis and control
Read the detailed description
Sleep is essential for daytime functioning and health and important for both psychological and physiological wellbeing . A growing body of research indicates that chronic sleep disturbance is associated with impaired quality of life (QoL) and a risk factor for poorer health, for example depression cardiovascular disease, hypertension 1 and diabetes.
insomnia, the most common sleep disorder, is a clinical condition defined as difficulties falling asleep and/or maintaining sleep and/or poor sleep quality despite adequate opportunity for sleep resulting in significant daytime impairment.
The development of insomnia in healthy populations has a bi-directional relationship with psychological factors such as anxiety, depressive symptoms and stress, and may in clinical populations also be associated with physical symptoms, such as pain. the physical symptoms in psoriasis, such as itch, one would expect a higher prevalence of sleep disturbance in this patient group. On the other hand Sleep disturbance is common also in patients with atopic dermatitis (AD). Patients with AD often have sleep disturbances due to pruritus.
- Conditions
- Sleep Disturbance
- Being tested
- sleep disturbance
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep disturbanceBehavioural
we observe sleep disturbance among patients with psoriasis and atopic dermatitis and control group
| Study group | Role | What they receive |
|---|---|---|
| psoriasis patients | sleep disturbance Receives: Behavioral: sleep disturbance | |
| atopic dermatites patients | sleep disturbance Receives: Behavioral: sleep disturbance | |
| control | sleep disturbance Receives: Behavioral: sleep disturbance |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of the psooriasis (Psoriasis Area and Severity Index)
calculation of the severity through questionaire , 0 = None
- = Slight
- = Moderate
- = Severe
- = Very severe
Measured: 1 hour
Secondary outcomes (7)
2.HRQoL (Dermatology Life Quality Index);
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER THE LAST WEEK The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: 1 hour
.insomnia severity [Insomnia Severity Index (ISI)];
The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score. When you have your total score
Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: 1 hour
sleep quality [Pittsburgh Sleep Quality Index (PSQI)];
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.
A total score of "5" or greater is indicative of poor sleep quality. If you scored "5" or more it is suggested that you discuss your sleep habits with a healthcare provider
Measured: 1 hour
stress (Perceived Stress Scale);
The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful.
0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often
Measured: 1 hour
itch (Itch Severity Scale);
The ISS consists of seven questions that measure the severity of itch and the extent to which QoL is affected. The total score ranges from zero to 21
Measured: 1 hour
and depressive symptoms (Beck Depression Inventory
This depression inventory can be self-scored 1-10____________________These ups and downs are considered normal 11-16___________________ Mild mood disturbance 17-20___________________Borderline clinical depression 21-30___________________Moderate depression 31-40___________________Severe depression over 40__________________Extreme depression
Measured: 1 hour
severity of a topic dermatitis
The eczema area and severity index (EASI) Mild eczema score < 25 Moderate eczema score >25 <50 Severe eczema score >50
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Jun 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Mahmoud Abdelmohsen, Assiut University
- Investigators
- radwa bakr, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864809
- Sponsor's protocol ID
- SL disturb in psoriasis atopy
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jensen P, Zachariae C, Skov L, Zachariae R. Sleep disturbance in psoriasis: a case-controlled study. Br J Dermatol. 2018 Dec;179(6):1376-1384. doi: 10.1111/bjd.16702. Epub 2018 Aug 23.
PubMed 29704428
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- • Sleep Disturbance Among Patients With Psoriasis and Atopy and Comparison Between Them
- ClinicalTrials.gov ID
- NCT03864809
- Acronym / sponsor ID
- SL disturb in psoriasis atopy
- Conditions
- Sleep Disturbance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 6 Mar 2019 (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.
Comparison between sleep disturbance in atopy and psoriasis and control
Detailed description
Sleep is essential for daytime functioning and health and important for both psychological and physiological wellbeing . A growing body of research indicates that chronic sleep disturbance is associated with impaired quality of life (QoL) and a risk factor for poorer health, for example depression cardiovascular disease, hypertension 1 and diabetes.
insomnia, the most common sleep disorder, is a clinical condition defined as difficulties falling asleep and/or maintaining sleep and/or poor sleep quality despite adequate opportunity for sleep resulting in significant daytime impairment.
The development of insomnia in healthy populations has a bi-directional relationship with psychological factors such as anxiety, depressive symptoms and stress, and may in clinical populations also be associated with physical symptoms, such as pain. the physical symptoms in psoriasis, such as itch, one would expect a higher prevalence of sleep disturbance in this patient group. On the other hand Sleep disturbance is common also in patients with atopic dermatitis (AD). Patients with AD often have sleep disturbances due to pruritus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| psoriasis patients | – | Behavioral: sleep disturbancesleep disturbance |
| atopic dermatites patients | – | Behavioral: sleep disturbancesleep disturbance |
| control | – | Behavioral: sleep disturbancesleep disturbance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study involves the use of seven questionnaires to be given to subjects with psoriasis and a topic dermatites
Key inclusion criteria (1 listed)
- patients with Psoriasis and Patients with A topic dermatitis
Key exclusion criteria (1 listed)
- All patient have another dermatological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep disturbancewe observe sleep disturbance among patients with psoriasis and atopic dermatitis and control group | Behavioural | atopic dermatites patients, control, psoriasis patients |
Primary outcome
severity of the psooriasis (Psoriasis Area and Severity Index)
Time frame: 1 hour
calculation of the severity through questionaire , 0 = None 1. = Slight 2. = Moderate 3. = Severe 4. = Very severe
7 secondary outcomes
2.HRQoL (Dermatology Life Quality Index);
Time frame: 1 hour
.insomnia severity [Insomnia Severity Index (ISI)];
Time frame: 1 hour
sleep quality [Pittsburgh Sleep Quality Index (PSQI)];
Time frame: 1 hour
stress (Perceived Stress Scale);
Time frame: 1 hour
itch (Itch Severity Scale);
Time frame: 1 hour
and depressive symptoms (Beck Depression Inventory
Time frame: 1 hour
severity of a topic dermatitis
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Background: PubMed 29704428Jensen P, Zachariae C, Skov L, Zachariae R. Sleep disturbance in psoriasis: a case-controlled study. Br J Dermatol. 2018 Dec;179(6):1376-1384. doi: 10.1111/bjd.16702. Epub 2018 Aug 23.
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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.
radwa bakr, lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disturbance, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 manai mahmoud, Bachelor's (1025191410, amanimahmoud43@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of the psooriasis (Psoriasis Area and Severity Index) (time frame: 1 hour). 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 NCT03864809, which also lists 1 linked publication.
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 7 Mar 2019.