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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Psoriasis Vulgaris

Treatments

Other: Polysomnography (PSG)

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05102474
DREAMS-PSO

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

24 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Tina Bhutani, MD, MAS

Data sourced from clinicaltrials.gov

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