Prevalence of Sleep Disturbances in Psoriasis

NCT ID: NCT00895375

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-12-31

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.

Conditions

Psoriasis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Psoriasis patients

40 subjects (male or female) age 18 or older with psoriasis covering \>10% BSA and without a diagnosis of depression.

No interventions assigned to this group

Patients without psoriasis

40 subjects without psoriasis matched for age, sex and BMI, as a control population.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Chronic plaque psoriasis (at least 6 months)

Exclusion Criteria

• Active depression

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences, Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00008291

Identifier Type: -

Identifier Source: org_study_id