Sleep Disturbance in Atopic Dermatitis: A Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology

Wake Forest University1 site in 1 country31 target enrollmentMarch 2006

ConditionsAtopic Dermatitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Wake Forest University
Enrollment: 31
Locations: 1
Primary Endpoint: To assess whether there are differences in dermal and serum opiate levels and neuropeptides involved in atopic dermatitis between day and night
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to study the sleep patterns of people with moderate to severe atopic dermatitis and how itching affects those patterns. This study will also measure your body's activity during sleep using non-invasive tests described below.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

December 2009

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Wake Forest University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult men and women who are between 18 and 50 years of age
•Diagnosis of moderate to severe atopic dermatitis including involvement of the forearm confirmed by published consensus diagnostic criteria57 (except for healthy control subjects)
•Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of their skin or which would increase their health risk by study participation
•Subjects must be willing to stay overnight in the sleep laboratory and/or to undergo dermal microdialysis
•Women of child bearing age will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study.

Exclusion Criteria

•Adults over age 50
•Children less than 18 years of age.
•Unable to complete the required measures
•Diagnosis with other skin diseases that would affect the measurement of transepidermal water loss (TEWL) as determined by the investigators
•Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and patients undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation
•Evidence of depression based on the Beck Depression Inventory (BDI \> 10)
•Evidence of sleep apnea based on the results of the Epworth Sleepiness Scale score (ESS \> 10)
•Evidence of insomnia based on the Insomnia Severity Index (ISI) that is determined by the principal investigator to be unrelated to atopic dermatitis
•Individuals who work shifts between 8 pm and 6 am because such night shifts can alter subjects' circadian rhythms.
•Typically sleep less than 5 hours per night