Overview

This trial is active, not recruiting.

Condition psoriasis
Sponsor Wake Forest School of Medicine
Start date October 2009
End date February 2011
Trial size 80 participants
Trial identifier NCT00895375, IMM 08-0087

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
40 subjects (male or female) age 18 or older with psoriasis covering >10% BSA and without a diagnosis of depression.
40 subjects without psoriasis matched for age, sex and BMI, as a control population.

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).
time frame: 1 year

Secondary Outcomes

Measure
Measured prevalence of poor sleep quality in control subjects using the PSQI in order to compare against psoriasis subjects.
time frame: 1 year
Measured prevalence of insomnia in both groups assessed by the Insomnia Severity Index.
time frame: 1 year
Measured prevalence of hypersomnia in both groups assessed by the Epworth Sleepiness Scale.
time frame: 1 year
Measured prevalence of pruritus in both groups assessed by Itch Severity Scale (ISS).
time frame: 1 year
Measured prevalence of depression in both groups assessed by Patient Health Questionnaire (PHQ-9).
time frame: 1 year
Measure prevalence of sleep disordered breathing in both groups assessed by Snore Outcome Survey (SOS).
time frame: 1 year
Measured prevalence of pruritus, depression, and sleep disordered breathing in those with impaired sleep.
time frame: 1 year
Measured prevalence of depression in subjects with pruritus and sleep-disordered breathing.
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Chronic plaque psoriasis (at least 6 months) Exclusion Criteria: - Active depression

Additional Information

Official title Prevalence of Sleep Disturbances in Psoriasis
Principal investigator Steven Feldman, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.