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

Shanghai Yueyang Integrated Medicine Hospital

Status: Not yet enrolling

Conditions: Moderate-to-severe Psoriasis

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06165887

20231008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

156 participants in 2 patient groups

Moderate-to-severe Psoriasis patients

Description:

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

Treatment:

Other: No intervention

Other: No intervention

Healthy people

Description:

Participants will fill out questionnaires to assess sleep status

Treatment:

Other: No intervention

Other: No intervention