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Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis

Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05102474
Acronym
DREAMS-PSO
Enrollment
24
Registered
2021-11-01
Start date
2022-02-15
Completion date
2024-07-03
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

Brief 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. 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.

Interventions

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.

Sponsors

Novartis Pharmaceuticals
CollaboratorINDUSTRY
National Psoriasis Foundation
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. 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. 2. Are at least 18 years of age 3. Psoriasis has been stable over the last 3 months 4. Psoriasis is either untreated or treated only with topicals at the current time (see

Exclusion criteria

for washout times) 5. Subjectively reported poor sleep quality using the Pittsburg Sleep Quality Index (PSQI) (defined as a global score \>5) 6. Fluent in English 7. Demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent

Design outcomes

Primary

MeasureTime frameDescription
Sleep efficiencyAverage over 3 consecutive nights of sleepSleep efficiency is defined as the percentage of time spent asleep while in bed.

Secondary

MeasureTime frameDescription
Total sleep timeAverage over 3 consecutive nights of sleepTotal sleep time is the total amount of sleep time recorded during the total recording time (each night)
Sleep onset latencyAverage over 3 consecutive nights of sleepSleep onset latency is defines as the duration of time from turning off the light to falling asleep.
Wake after sleep onsetAverage over 3 consecutive nights of sleepWake after sleep onset is defined as the time between when they first fall asleep to when they become fully awake.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026