About this trial
Psoriasis is a common chronic and systemic immune-mediated disease, induced by a combination of genetic and environmental effects. The increasingly worrying question is the negative impact on patients' sleep, which has become an important comorbidity of psoriasis. To investigate the causal relationship between psoriasis and sleep status, a prospective cohort study will be conducted by separating moderate-to-severe psoriasis patients and healthy individuals into distinct cohorts in order to observe their sleep status.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
In line with the diagnostic criteria of psoriasis
PASI>10 or BSA>10%
Understand and agree to participate in this study and sign the informed consent.
Disqualifiers
Those with serious mental diseases, such as depression, anxiety, etc;
PSQI>5 points;
Long term use of sedative and hypnotic drugs;
Patients with diabetes mellitus or severe heart, liver and kidney disease;
Trial population
patients with psoriasis and healthy people
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionThis is an observational study, no intervention will be implemented.
No intervention
Other interventionThis is an observational study, no intervention will be implemented.
Treatment groups
Trial outcomes
Primary outcomes
Pittsburgh sleep quality index (PSQI)
PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. A score above 5 suggests poor sleep quality.
Secondary outcomes
Psoriasis Area and Severity Index (PASI)
The PASI score ranges from 0 to 72, and the higher the score, the more serious the patient's condition. Generally speaking, a PASI score of less than 10 indicates mild psoriasis, 10-20 indicates moderate psoriasis, and more than 20 indicates severe psoriasis.
Dermatology Life Quality Index (DLQI)
DLQI was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL.
Visual Analogue Scale (VAS)
The scoring criteria for pruritus level are as follows: absence of pruritus = 0; mild (intermittent itching, no scratching, no interference with daily activities) = 1-3 points; moderate (frequent itching, occasional scratching, impacting daily routine and sleep) = 4-6 points, and severe (intense itching, persistent scratching, significantly affecting daily life and sleep) = 7-10 points.
Hospital Anxiety and Depression Scale(HADS)
For describing depression and anxiety in hospital patients
Sponsors and contacts
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