NCT00895375

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

May 7, 2009

Last Update Submit

July 3, 2018

Conditions

Psoriasis

Keywords

DermatologySkinPsoriasisSleepWake ForestInsomnia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the Wake Forest University Physicians outpatient clinics

You may qualify if:

  • Chronic plaque psoriasis (at least 6 months)

You may not qualify if:

  • Active depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences, Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

PsoriasisSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Steven Feldman, MD, PhD

    Department of Dermatology, Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2011

Study Completion

December 1, 2014

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(1)