Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis
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
🗓️ Study Start (Actual) 15 February 2022
🗓️ Primary Completion (Estimated) 31 May 2024
✅ Study Completion (Estimated) 31 May 2024
👥 Enrollment (Estimated) 24
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 October 2021
  • First Submitted that Met QC Criteria 19 October 2021
  • First Posted 1 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 May 2024
  • Last Update Posted 8 May 2024
  • Last Verified May 2024