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

Moderate-to-severe Psoriasis Clinical Trial

Official title:

The Relationship Between Moderate-to-severe Psoriasis and Sleep Disturbance: a Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06165887
• Other study ID #: 20231008
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: Xin Li, PHD
• Phone: 13661956326
• Email: 13661956326[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Moderate-to-severe Psoriasis
• Parasomnias
• Psoriasis

Intervention

Other:
• No intervention
This is an observational study, no intervention will be implemented.
• No intervention
This is an observational study, no intervention will be implemented.

Locations

Country	Name	City	State
China	Shanghai Yueyang Integrated Medicine Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week0?week8?week16?week24
Secondary	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.	week0?week8?week16?week24
Secondary	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.	week0?week8?week16?week24
Secondary	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.	week0?week8?week16?week24
Secondary	Hospital Anxiety and Depression Scale(HADS)	For describing depression and anxiety in hospital patients	week0?week8?week16?week24