Clinical trial NCT06165887: The Relationship Between Moderate-to-severe Psoriasis and Sleep Disturbance
Official title: The Relationship Between Moderate-to-severe Psoriasis and Sleep Disturbance: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Moderate-to-severe Psoriasis
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with psoriasis and healthy people

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: week0、week8、week16、week24
Secondary outcomes:
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: week0、week8、week16、week24
measure: Dermatology Life Quality Index (DLQI)
timeFrame: week0、week8、week16、week24
measure: Visual Analogue Scale (VAS)
timeFrame: week0、week8、week16、week24
measure: Hospital Anxiety and Depression Scale(HADS）
timeFrame: week0、week8、week16、week24
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Medicine Hospital
state: Shanghai
Study officials:
References: