Prevalence of Sleep Disturbances in Psoriasis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00895375
First received: May 7, 2009
Last updated: May 27, 2014
Last verified: May 2014
  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 School of Medicine:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measured prevalence of poor sleep quality in control subjects using the PSQI in order to compare against psoriasis subjects. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measured prevalence of insomnia in both groups assessed by the Insomnia Severity Index. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measured prevalence of hypersomnia in both groups assessed by the Epworth Sleepiness Scale. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measured prevalence of pruritus in both groups assessed by Itch Severity Scale (ISS). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measured prevalence of depression in both groups assessed by Patient Health Questionnaire (PHQ-9). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measure prevalence of sleep disordered breathing in both groups assessed by Snore Outcome Survey (SOS). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measured prevalence of pruritus, depression, and sleep disordered breathing in those with impaired sleep. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Measured prevalence of depression in subjects with pruritus and sleep-disordered breathing. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2009
Estimated Study Completion Date: October 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895375

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

No publications provided

Responsible Party: Steven R. Feldman, Professor of Dermatology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00895375     History of Changes
Other Study ID Numbers: IMM 08-0087
Study First Received: May 7, 2009
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Dermatology
Skin
Psoriasis
Sleep
Wake Forest
Insomnia

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

ClinicalTrials.gov processed this record on September 18, 2014