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Completed

NCT Number: NCT05102474

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Psorisis Center

San Francisco, California, 94118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total sleep time

    Time frame: Average over 3 consecutive nights of sleep

    Total sleep time is the total amount of sleep time recorded during the total recording time (each night)

  2. Sleep onset latency

    Time frame: Average over 3 consecutive nights of sleep

    Sleep onset latency is defines as the duration of time from turning off the light to falling asleep.

  3. Wake after sleep onset

    Time frame: Average over 3 consecutive nights of sleep

    Wake after sleep onset is defined as the time between when they first fall asleep to when they become fully awake.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Psoriasis Foundation
  • Novartis Pharmaceuticals

Registry information

Acronym: DREAMS-PSO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2021
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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