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

NCT05102474 | Completed

• 1 other identifier: DREAMS-PSO
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Sleep efficiency

  Sleep efficiency is defined as the percentage of time spent asleep while in bed.

  Average over 3 consecutive nights of sleep

Secondary Outcomes (3)

• Total sleep time

  Average over 3 consecutive nights of sleep

• Sleep onset latency

  Average over 3 consecutive nights of sleep

• Wake after sleep onset

  Average over 3 consecutive nights of sleep

Study Arms (2)

Moderate to Severe Psoriasis

Moderate to severe psoriasis will be defined as affected body surface area (BSA) ≥3%.

Other: Polysomnography (PSG)

Healthy Controls

Healthy controls will be age and sex matched subjects with no prior or current history of psoriasis.

Other: Polysomnography (PSG)

Interventions

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.

Healthy Controls; Moderate to Severe Psoriasis

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Novartis Pharmaceuticals: collaborator
• National Psoriasis Foundation: collaborator

Study Sites (1)

UCSF Psorisis Center

San Francisco, California, 94118, United States

Location

Study Officials

• Tina Bhutani, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 1, 2021
• Study Start: February 15, 2022
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)