Psoriasis VulgarisDREAMS-PSONCT05102474
Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis
An observational study of Psoriasis Vulgaris, run by University of California, San Francisco at 1 site in United States.
Trial summary
Getting enough sleep is important for maximizing health and well-being. When it comes to health, sleep is as vital as regular exercise and eating a balanced diet. Not getting enough sleep can lead to health problems like heart attacks, diabetes, and even cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Polysomnography (PSG)
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 3 Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 24 patients (12 moderate-to-severe psoriasis and 12 healthy controls, age and sex matched) will be recruited for this study.
Who may be able to join
- Patients with a diagnosis of moderate to severe plaque type psoriasis confirmed by the principal investigator. Moderate to severe psoriasis will be defined as affected BSA ≥3%. Healthy controls will be age and sex matched (see below) subjects with no prior or current history of psoriasis.
- Are at least 18 years of age
- Psoriasis has been stable over the last 3 months
- Psoriasis is either untreated or treated only with topicals at the current time (see exclusion criteria for washout times)
- Subjectively reported poor sleep quality using the Pittsburg Sleep Quality Index (PSQI) (defined as a global score >5)
- Fluent in English
- Demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent
Who cannot join
- Patients with guttate, erythrodermic, or pustular psoriasis subtypes
- Having a previous diagnosis of obstructive sleep apnea (OSA) or another medically defined sleep disorder or fall into the intermediate or high-risk groups for having OSA as calculated by the STOP-BANG questionnaire
- Subjects who have used the following treatments for psoriasis: phototherapy (UVB) in the last 2 weeks, photochemotherapy (PUVA) in the last 4 weeks, oral systemic treatments in the last 4 weeks, biologic immunomodulating agents in the last 12 weeks, or have had exposure to any other investigational drug/device within 30 days prior to study entry
- Subjects who have used any over the counter or prescription sleep aids within five half-lives of the agent in question.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psorisis Center
San Francisco, California, 94118
About this study
Getting enough sleep is important for maximizing health and well-being. When it comes to health, sleep is as vital as regular exercise and eating a balanced diet. Not getting enough sleep can lead to health problems like heart attacks, diabetes, and even cancer. Since individuals with psoriasis have these same health problems, getting better sleep may help to keep them happier and healthier. This study will look at how individuals with psoriasis sleep and if their sleep is different than indivuduals without psoriasis.
Read the detailed description
A growing body of literature has revealed that individuals with psoriasis are more likely to report sleep disturbance when compared to the general population. The cross-sectional study presented here will allow the investigators to objectively and rigorously measure sleep architecture in psoriasis patients and compare it to healthy controls, If sleep dysfunction is confirmed in this population, then clinical interventions such as screening for sleep disturbance or promoting sleep hygiene could lead to meaningful improvements in patients' health, longevity, and overall quality of life.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Polysomnography (PSG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography (PSG)Other
PSG is the gold standard for objectively measuring sleep in the laboratory setting. The procedure consists of electrodes measuring brain activity (electroencephalography, EEG), eye movements (electrooculography, EOG), muscle activity (electromyography, EMG), respiratory events, snoring activity, blood oxygen saturation, and body position. Video surveillance during the sleep study can also monitor for itching events that occur during the night.
| Study group | Role | What they receive |
|---|---|---|
| Moderate to Severe Psoriasis | Moderate to severe psoriasis will be defined as affected body surface area (BSA) ≥3%. Receives: Other: Polysomnography (PSG) | |
| Healthy Controls | Healthy controls will be age and sex matched subjects with no prior or current history of psoriasis. Receives: Other: Polysomnography (PSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
Sleep efficiency is defined as the percentage of time spent asleep while in bed.
Measured: Average over 3 consecutive nights of sleep
Secondary outcomes (3)
Total sleep time
Total sleep time is the total amount of sleep time recorded during the total recording time (each night)
Measured: Average over 3 consecutive nights of sleep
Sleep onset latency
Sleep onset latency is defines as the duration of time from turning off the light to falling asleep.
Measured: Average over 3 consecutive nights of sleep
Wake after sleep onset
Wake after sleep onset is defined as the time between when they first fall asleep to when they become fully awake.
Measured: Average over 3 consecutive nights of sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start15 Feb 2022
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, National Psoriasis Foundation
- Responsible party
- Sponsor
- Investigators
- Tina Bhutani, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102474
- Sponsor's protocol ID
- DREAMS-PSO
- Acronym
- DREAMS-PSO
- Status last verified
- Aug 2025
- First submitted
- 18 Oct 2021
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis
- ClinicalTrials.gov ID
- NCT05102474
- Acronym / sponsor ID
- DREAMS-PSO / DREAMS-PSO
- Conditions
- Psoriasis Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, National Psoriasis Foundation
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 1 Nov 2021 (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.
Getting enough sleep is important for maximizing health and well-being. When it comes to health, sleep is as vital as regular exercise and eating a balanced diet. Not getting enough sleep can lead to health problems like heart attacks, diabetes, and even cancer. Since individuals with psoriasis have these same health problems, getting better sleep may help to keep them happier and healthier. This study will look at how individuals with psoriasis sleep and if their sleep is different than indivuduals without psoriasis.
Detailed description
A growing body of literature has revealed that individuals with psoriasis are more likely to report sleep disturbance when compared to the general population. The cross-sectional study presented here will allow the investigators to objectively and rigorously measure sleep architecture in psoriasis patients and compare it to healthy controls, If sleep dysfunction is confirmed in this population, then clinical interventions such as screening for sleep disturbance or promoting sleep hygiene could lead to meaningful improvements in patients' health, longevity, and overall quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate to Severe Psoriasis | – | Other: Polysomnography (PSG)Moderate to severe psoriasis will be defined as affected body surface area (BSA) ≥3%. |
| Healthy Controls | – | Other: Polysomnography (PSG)Healthy controls will be age and sex matched subjects with no prior or current history of psoriasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 24 patients (12 moderate-to-severe psoriasis and 12 healthy controls, age and sex matched) will be recruited for this study.
Key inclusion criteria (7 listed)
- Patients with a diagnosis of moderate to severe plaque type psoriasis confirmed by the principal investigator. Moderate to severe psoriasis will be defined as affected BSA ≥3%. Healthy controls will be age and sex matched (see below) subjects with no prior or current history of psoriasis.
- Are at least 18 years of age
- Psoriasis has been stable over the last 3 months
- Psoriasis is either untreated or treated only with topicals at the current time (see exclusion criteria for washout times)
- Subjectively reported poor sleep quality using the Pittsburg Sleep Quality Index (PSQI) (defined as a global score >5)
Key exclusion criteria (4 listed)
- Patients with guttate, erythrodermic, or pustular psoriasis subtypes
- Having a previous diagnosis of obstructive sleep apnea (OSA) or another medically defined sleep disorder or fall into the intermediate or high-risk groups for having OSA as calculated by the STOP-BANG questionnaire
- Subjects who have used the following treatments for psoriasis: phototherapy (UVB) in the last 2 weeks, photochemotherapy (PUVA) in the last 4 weeks, oral systemic treatments in the last 4 weeks, biologic immunomodulating agents in the last 12 weeks, or have had exposure to any other investigational drug/device within 30 days prior to study entry
- Subjects who have used any over the counter or prescription sleep aids within five half-lives of the agent in question.
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 |
|---|---|---|
| Polysomnography (PSG)PSG is the gold standard for objectively measuring sleep in the laboratory setting. The procedure consists of electrodes measuring brain activity (electroencephalography, EEG), eye movements (electrooculography, EOG), muscle activity (electromyography, EMG), respiratory events, snoring activity, blood oxygen saturation, and body position. Video surveillance during the sleep study can also monitor for itching events that occur during the night. | Other | Healthy Controls, Moderate to Severe Psoriasis |
Primary outcome
Sleep efficiency
Time frame: Average over 3 consecutive nights of sleep
Sleep efficiency is defined as the percentage of time spent asleep while in bed.
3 secondary outcomes
Total sleep time
Time frame: Average over 3 consecutive nights of sleep
Sleep onset latency
Time frame: Average over 3 consecutive nights of sleep
Wake after sleep onset
Time frame: Average over 3 consecutive nights of sleep
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Tina Bhutani, MD, MAS principal investigator
University of California, San Francisco
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 Psoriasis Vulgaris, run by University of California, San Francisco at 1 site in United States.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 6 Aug 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: Average over 3 consecutive nights of sleep). 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 6 Aug 2025.