Moderate-to-severe PsoriasisNCT06165887
The Relationship Between Moderate-to-severe Psoriasis and Sleep Disturbance
An observational study of Moderate-to-severe Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate-to-severe Psoriasis
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- Feb 2024to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with psoriasis and healthy people
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality, 200080
About this study
Official title: 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.
Read the 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.
- Conditions
- Moderate-to-severe Psoriasis
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study, no intervention will be implemented.
No interventionOther
This is an observational study, no intervention will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-severe Psoriasis patients | Participants will fill out questionnaires to assess sleep status and the severity of psoriasis. Receives: Other: No intervention | |
| Healthy people | Participants will fill out questionnaires to assess sleep status Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week0、week8、week16、week24
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: week0、week8、week16、week24
Hospital Anxiety and Depression Scale(HADS）
For describing depression and anxiety in hospital patients
Measured: week0、week8、week16、week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165887
- Sponsor's protocol ID
- 20231008
- Status last verified
- Feb 2024
- First submitted
- 3 Dec 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Moderate-to-severe Psoriasis and Sleep Disturbance: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06165887
- Acronym / sponsor ID
- 20231008
- Conditions
- Moderate-to-severe Psoriasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-severe Psoriasis patients | – | Other: No interventionParticipants will fill out questionnaires to assess sleep status and the severity of psoriasis. |
| Healthy people | – | Other: No interventionParticipants will fill out questionnaires to assess sleep status |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with psoriasis and healthy people
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study, no intervention will be implemented. | Other | Moderate-to-severe Psoriasis patients |
| No interventionThis is an observational study, no intervention will be implemented. | Other | Healthy people |
Primary outcome
Pittsburgh sleep quality index (PSQI)
Time frame: week0、week8、week16、week24
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.
4 secondary outcomes
Psoriasis Area and Severity Index (PASI)
Time frame: week0、week8、week16、week24
Dermatology Life Quality Index (DLQI)
Time frame: week0、week8、week16、week24
Visual Analogue Scale (VAS)
Time frame: week0、week8、week16、week24
Hospital Anxiety and Depression Scale(HADS）
Time frame: week0、week8、week16、week24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate-to-severe Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Li, PHD (13661956326, 13661956326@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index (PSQI) (time frame: week0、week8、week16、week24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.