The Relationship Between Moderate-to-severe Psoriasis and Sleep Disturbance

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorShanghai Yueyang Integrated Medicine Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    This is an observational study, no intervention will be implemented.

  • No intervention

    Other intervention

    This is an observational study, no intervention will be implemented.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Moderate-to-severe Psoriasis patients1 intervention
Group B: Healthy people1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
week0、week8、week16、week24

Secondary outcomes

1

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.

Time frame
week0、week8、week16、week24
2

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.

Time frame
week0、week8、week16、week24
3

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.

Time frame
week0、week8、week16、week24
4

Hospital Anxiety and Depression Scale(HADS)

For describing depression and anxiety in hospital patients

Time frame
week0、week8、week16、week24

Other outcomes

Sponsors and contacts

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