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Prevalence of Sleep Disturbances in Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00895375
First Posted: May 8, 2009
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
The purpose of this study is to compare the sleep quality of patients with psoriasis to patients without psoriasis.

Condition
Psoriasis

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Sleep Disturbances in Psoriasis

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: October 2009
Study Completion Date: December 2014
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Psoriasis patients
40 subjects (male or female) age 18 or older with psoriasis covering >10% BSA and without a diagnosis of depression.
Patients without psoriasis
40 subjects without psoriasis matched for age, sex and BMI, as a control population.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients from the Wake Forest University Physicians outpatient clinics
Criteria

Inclusion Criteria:

  • Chronic plaque psoriasis (at least 6 months)

Exclusion Criteria:

  • Active depression
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895375


Locations
United States, North Carolina
Wake Forest University Health Sciences, Dermatology
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Steven Feldman, MD, PhD Department of Dermatology, Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00895375     History of Changes
Other Study ID Numbers: IMM 08-0087
First Submitted: May 7, 2009
First Posted: May 8, 2009
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Wake Forest University Health Sciences:
Dermatology
Skin
Psoriasis
Sleep
Wake Forest
Insomnia

Additional relevant MeSH terms:
Psoriasis
Dyssomnias
Sleep Wake Disorders
Parasomnias
Skin Diseases, Papulosquamous
Skin Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms