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

NCT06165887 | Not Yet Recruiting DMC

• 1 other identifier: 20231008
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate-to-severe Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Psoriasis Area and Severity Index (PASI)

  week0、week8、week16、week24

• Dermatology Life Quality Index (DLQI)

  week0、week8、week16、week24

• Visual Analogue Scale (VAS)

  week0、week8、week16、week24

• Hospital Anxiety and Depression Scale(HADS）

  week0、week8、week16、week24

Study Arms (2)

Moderate-to-severe Psoriasis patients

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

Other: No intervention

Healthy people

Participants will fill out questionnaires to assess sleep status

Other: No intervention

Interventions

No intervention OTHER

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

Moderate-to-severe Psoriasis patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with psoriasis and healthy people

You may qualify if:

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

You may not qualify if:

• Those with serious mental diseases, such as depression, anxiety, etc;
• PSQI\>5 points;
• Long term use of sedative and hypnotic drugs;
• Patients with diabetes mellitus or severe heart, liver and kidney disease;
• Those diagnosed with sleep disorders, such as apnea syndrome, periodic limb movement disorder, restless legs syndrome, narcolepsy, etc;
• There are serious cardiovascular and cerebrovascular diseases, respiratory system diseases, and immune system diseases;
• Pregnant women during pregnancy, lactation, or planned trials;
• Those who have participated in other clinical studies or are participating in other clinical trials within 3 months;
• 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.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Central Study Contacts

Xin Li, PHD

CONTACT

13661956326; 13661956326@163.com

Pengbo Gao, bachelor

CONTACT

13584213753; 13584213753@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 12, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CN (1)