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

Psoriasis Vulgaris Clinical Trial

— DREAMS-PSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05102474
• Other study ID #: DREAMS-PSO
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Tina Bhutani, MD, MAS
• Phone: 415-944-7618
• Email: psoriasis[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Other:
• Polysomnography (PSG)
PSG is the gold standard for objectively measuring sleep in the laboratory setting. The procedure consists of electrodes measuring brain activity (electroencephalography, EEG), eye movements (electrooculography, EOG), muscle activity (electromyography, EMG), respiratory events, snoring activity, blood oxygen saturation, and body position. Video surveillance during the sleep study can also monitor for itching events that occur during the night.

Locations

Country	Name	City	State
United States	UCSF Psorisis Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Psoriasis Foundation, Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency	Sleep efficiency is defined as the percentage of time spent asleep while in bed.	Average over 3 consecutive nights of sleep
Secondary	Total sleep time	Total sleep time is the total amount of sleep time recorded during the total recording time (each night)	Average over 3 consecutive nights of sleep
Secondary	Sleep onset latency	Sleep onset latency is defines as the duration of time from turning off the light to falling asleep.	Average over 3 consecutive nights of sleep
Secondary	Wake after sleep onset	Wake after sleep onset is defined as the time between when they first fall asleep to when they become fully awake.	Average over 3 consecutive nights of sleep