Clinical trial NCT00895375: Prevalence of Sleep Disturbances in Psoriasis
Official title: Prevalence of Sleep Disturbances in Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Dermatology
Skin
Psoriasis
Sleep
Wake Forest
Insomnia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2009-05-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Wake Forest University Physicians outpatient clinics

Brief summary: The purpose of this study is to compare the sleep quality of patients with psoriasis to patients without psoriasis.

Detailed description: In psoriasis, the burden of disease extends well beyond physical manifestations and can be associated with significant physical, social and psychological impairments. The impact of psoriasis on quality of life has been extensively investigated and demonstrates a negative affect on activities of daily living including sleep. Sleep abnormalities have also been reported in other dermatologic diseases including atopic dermatitis. However, there is relatively little data on the impact of psoriasis on sleep quality and what factors are likely to cause sleep disturbances. Obtaining this information is important because both psoriasis and sleep disorders are associated with cardiovascular disease. A better understanding of sleep problems in psoriasis may help to further our knowledge of psoriasis co-morbidities.

Certain factors associated with psoriasis, including pruritus, depression, and sleep-disordered breathing (obstructive sleep apnea) can independently affect sleep. It would be of particular interest to assess the effect of these factors on sleep quality in psoriasis subjects and the control group to determine what type of sleep problems exist among patients with psoriasis.

This study involves the use of six questionnaires to be given to subjects with psoriasis covering \>10% BSA and 40 subjects without psoriasis matched for age, gender and BMI, as a control population. The questionnaires will be given to subjects when they come for their scheduled appointments. The surveys will be completed anonymously and will be collected by a staff member when they are done. A physician will determine the participants' disease severity using the Psoriasis Area and Severity Index (PASI) and will attach the score to their questionnaire.

The questionnaires will cover sleep quality, depression, pruritis, insomnia, hypersomnia, and sleep-disordered breathing. Subjects will be given standard instructions to follow written directions on each questionnaire and will be given an unlimited amount of time to complete the surveys.

Eligibility criteria: Inclusion Criteria:

* Chronic plaque psoriasis (at least 6 months)

Exclusion Criteria:

* Active depression

Primary outcomes:
measure: Measured prevalence of poor sleep quality in psoriasis subjects as compared to sex-, age-, and BMI-matched subjects without psoriasis, defined as the control population, will be assessed by the Pittsburgh Sleep Quality Index (PSQI).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences, Dermatology
state: North Carolina
Study officials:
affiliation: Department of Dermatology, Wake Forest University Health Sciences
name: Steven Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: