Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis (DREAMS-PSO)

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Other: Polysomnography (PSG)

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 Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Tina Bhutani, MD, MAS; Phone Number: 415-944-7618; Email: psoriasis@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94118
      • Recruiting
      • UCSF Psorisis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Exclusion Criteria:

1. Patients with guttate, erythrodermic, or pustular psoriasis subtypes
2. 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
3. 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
4. Subjects who have used any over the counter or prescription sleep aids within five half-lives of the agent in question.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderate to Severe Psoriasis; Moderate to severe psoriasis will be defined as affected body surface area (BSA) ≥3%.	Other: 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.
Healthy Controls; Healthy controls will be age and sex matched subjects with no prior or current history of psoriasis.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency	Sleep efficiency is defined as the percentage of time spent asleep while in bed.	Average over 3 consecutive nights of sleep

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sleep time	Total sleep time is the total amount of sleep time recorded during the total recording time (each night)	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.	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.	Average over 3 consecutive nights of sleep

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Novartis Pharmaceuticals; National Psoriasis Foundation
• Investigators: Principal Investigator: Tina Bhutani, MD, MAS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: DREAMS-PSO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No