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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

Study Description
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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.

Condition or disease Intervention/treatment
Psoriasis Vulgaris Other: Polysomnography (PSG)

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 Design
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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis
Actual Study Start Date : February 15, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Moderate to Severe Psoriasis
Moderate to severe psoriasis will be defined as affected body surface area (BSA) ≥3%.
 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.
Healthy Controls
Healthy controls will be age and sex matched subjects with no prior or current history of psoriasis.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05102474


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

Locations
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United States, California
UCSF Psorisis Center Recruiting
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Novartis Pharmaceuticals
National Psoriasis Foundation
Investigators
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Principal Investigator: Tina Bhutani, MD, MAS University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05102474    
Other Study ID Numbers: DREAMS-PSO
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases