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

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ClinicalTrials.gov Identifier: NCT05102474
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : April 5, 2022
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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