Evaluating sleep patterns in patients with moderate-to-severe psoriasis

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

This study is trying to see how sleep quality is affected in adults with moderate-to-severe psoriasis compared to healthy people, to help improve their sleep and overall health.

Quick facts

• Study type: Observational
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05102474 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess sleep quality and architecture in individuals with moderate-to-severe psoriasis compared to healthy controls. By utilizing polysomnography (PSG), the study will objectively measure sleep disturbances that may be more prevalent in psoriasis patients. The findings could lead to clinical interventions focused on improving sleep hygiene and overall health outcomes for those affected by psoriasis. The study will include participants aged 18 and older who have stable psoriasis and report poor sleep quality.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with moderate to severe plaque psoriasis and self-reported poor sleep quality.

Not a fit: Patients with other subtypes of psoriasis or those with diagnosed sleep disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved sleep quality and overall health for patients with psoriasis.

How similar studies have performed: Previous studies have indicated a correlation between psoriasis and sleep disturbances, suggesting that this approach is supported by existing literature.

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.

Where this trial is running

San Francisco, California

• UCSF Psorisis Center — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Tina Bhutani, MD, MAS — University of California, San Francisco
• Study coordinator: Tina Bhutani, MD, MAS

Conditions Psoriasis Vulgaris