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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Target follow-up duration for the study is 24 weeks, during which participants will undergo a sleep monitoring session every 8 weeks. The sleep monitoring data collected includes time to fall asleep, time to bed, sleep perception, and the Pittsburgh Sleep Quality Index (PSQI). The Dermatology Quality of Life Index (DLQI), the Psoriasis Area and Severity Index (PASI), and the Visual Analog Scale (VAS) will simultaneously be used to assess the severity of the disease in the cohort of patients with psoriasis.

Conditions

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Moderate-to-severe Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate-to-severe Psoriasis patients

Participants will fill out questionnaires to assess sleep status and the severity of psoriasis.

No intervention

Intervention Type OTHER

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

Healthy people

Participants will fill out questionnaires to assess sleep status

No intervention

Intervention Type OTHER

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

Interventions

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No intervention

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

Intervention Type OTHER

No intervention

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. In line with the diagnostic criteria of psoriasis
2. PASI\>10 or BSA\>10%
3. Understand and agree to participate in this study and sign the informed consent.

Exclusion Criteria

1. Those with serious mental diseases, such as depression, anxiety, etc;
2. PSQI\>5 points;
3. Long term use of sedative and hypnotic drugs;
4. Patients with diabetes mellitus or severe heart, liver and kidney disease;
5. Those diagnosed with sleep disorders, such as apnea syndrome, periodic limb movement disorder, restless legs syndrome, narcolepsy, etc;
6. There are serious cardiovascular and cerebrovascular diseases, respiratory system diseases, and immune system diseases;
7. Pregnant women during pregnancy, lactation, or planned trials;
8. Those who have participated in other clinical studies or are participating in other clinical trials within 3 months;
9. Unable to cooperate with the study for any reason, such as the following situation: language understanding, unable to complete the scale tester.

If any one of the above items is met, it shall be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes