Prevalence of Sleep Disturbances in Pso… | Clinical Trial

Key information

Conditions

Psoriasis Dyssomnias Mental Disorders Nervous System Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Health Sciences, Dermatology

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic plaque psoriasis (at least 6 months)

Exclusion criteria

Active depression

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2014
First posted: May 8, 2009
Registry last updated: Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed