Prevalence of Sleep Disturbances in Psoriasis

Psoriasis Clinical Trial

Official title:

Prevalence of Sleep Disturbances in Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895375
• Other study ID #: IRB00008291
• Status: Completed
• Start date: October 2009
• Est. completion date: December 2014

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2014
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic plaque psoriasis (at least 6 months)

Exclusion Criteria:

• Active depression

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Psoriasis
• Sleep Wake Disorders

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences, Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		1 year