Clinical trial NCT05102474: Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis
Official title: Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis Vulgaris
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
name: National Psoriasis Foundation
First posted: 2021-11-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep efficiency
timeFrame: Average over 3 consecutive nights of sleep
Secondary outcomes:
measure: Total sleep time
timeFrame: Average over 3 consecutive nights of sleep
measure: Sleep onset latency
timeFrame: Average over 3 consecutive nights of sleep
measure: Wake after sleep onset
timeFrame: Average over 3 consecutive nights of sleep
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Psorisis Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Tina Bhutani, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: