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

• ClinicalTrials.gov Identifier: NCT05102474
• Recruitment Status: Recruiting
• First Posted: November 1, 2021
• Last Update Posted: April 5, 2022
• Sponsor: University of California, San Francisco
• Collaborators: Novartis Pharmaceuticals; National Psoriasis Foundation
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: October 18, 2021
• First Posted Date: November 1, 2021
• Last Update Posted Date: April 5, 2022
• Actual Study Start Date: February 15, 2022
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2021)

Sleep efficiency [ Time Frame: Average over 3 consecutive nights of sleep ]

Sleep efficiency is defined as the percentage of time spent asleep while in bed.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 19, 2021)

• Total sleep time [ Time Frame: Average over 3 consecutive nights of sleep ]
  Total sleep time is the total amount of sleep time recorded during the total recording time (each night)
• Sleep onset latency [ Time Frame: Average over 3 consecutive nights of sleep ]
  Sleep onset latency is defines as the duration of time from turning off the light to falling asleep.
• Wake after sleep onset [ Time Frame: Average over 3 consecutive nights of sleep ]
  Wake after sleep onset is defined as the time between when they first fall asleep to when they become fully awake.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: 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.

Study Groups/Cohorts

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 19, 2021): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2023
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Tina Bhutani, MD, MAS; 415-944-7618; psoriasis@ucsf.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05102474
• Other Study ID Numbers: DREAMS-PSO
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current

Collaborators

• Novartis Pharmaceuticals
• National Psoriasis Foundation

Investigators

• Principal Investigator: Tina Bhutani, MD, MAS; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: March 2022