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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Moderate-to-severe Psoriasis
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 156

Contacts and Locations

• Study Contact: Name: Xin Li, PHD; Phone Number: 13661956326; Email: 13661956326@163.com
• Study Contact Backup: Name: Pengbo Gao, bachelor; Phone Number: 13584213753; Email: 13584213753@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai Yueyang Integrated Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients with psoriasis and healthy people

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderate-to-severe Psoriasis patients; Participants will fill out questionnaires to assess sleep status and the severity of psoriasis.	Other: No intervention; This is an observational study, no intervention will be implemented.
Healthy people; Participants will fill out questionnaires to assess sleep status	Other: No intervention; This is an observational study, no intervention will be implemented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Hospital Anxiety and Depression Scale(HADS）	For describing depression and anxiety in hospital patients	week0、week8、week16、week24

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Skin Diseases; Sleep Wake Disorders; Skin Diseases, Papulosquamous; Psoriasis; Dyssomnias; Parasomnias
• Other Study ID Numbers: 20231008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No