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

Recruiting

• Conditions: Psoriasis Vulgaris
• Interventions: Other: Polysomnography (PSG)

• Registration Number: NCT05102474
• Lead Sponsor: University of California, San Francisco

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-11-01
• Study Start: 2022-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Sleep efficiency	Average over 3 consecutive nights of sleep	Sleep efficiency is defined as the percentage of time spent asleep while in bed.

Secondary Outcome Measures

Name	Time	Method
Total sleep time	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)
Sleep onset latency	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.
Wake after sleep onset	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.

Trial Locations

Locations (1)

UCSF Psorisis Center; 🇺🇸 San Francisco, California, United States