Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology
This study is currently recruiting participants.
Verified by Wake Forest University, June 2008
Sponsored by: Wake Forest University
Information provided by: Wake Forest University
ClinicalTrials.gov Identifier: NCT00696397
  Purpose

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.


Condition
Atopic Dermatitis

U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Sleep Disturbance in Atopic Dermatitis: A Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • To assess whether there are differences in dermal and serum opiate levels and neuropeptides involved in atopic dermatitis between day and night [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood, dermal microdialysate


Estimated Enrollment: 15
Study Start Date: March 2006
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
adult men and women between 18 and 50 years of age with atopic dermatitis

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

adult men and women between 18 and 50 years of age with atopic dermatitis

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
  • Reported habitual bedtime earlier than 9pm or later than 1 am (> 2 times per week on screening diaries)
  • Reported habitual rising time later than 9 am (> 2 times per week on screening diaries
  • Diagnosis of sleep apnea, periodic limb movement disorder, or restless leg syndrome 58
  • Consumption of more than 3 alcoholic beverages per day
  • Consumption of more than 4 caffeinated beverages per day 59-61
  • Chronic pain judged to be a significant sleep-disturbing factor as determined by the investigators62
  • Current treatment with lipophilic beta blockers, opioids, glucocorticoids, theophylline, or other medications known to interfere with sleep as determined by the investigators 63-69
  • Uncontrolled asthma or COPD 70-73
  • Uncontrolled thyroid disease 74,75
  • Poorly controlled diabetes mellitus
  • Poorly compensated congestive heart failure 76
  • Use of herbal or naturopathic treatments for sleep
  • Habitual smoking between 11 pm and 7 am 77,78
  • Use of illicit drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696397

Contacts
Contact: Susie Dowd 336-7163775 sdowd@wfubmc.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology Recruiting
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Gil Yosipovitch, MD Wake Forest University
  More Information

Responsible Party: Wake Forest University Health Sciences ( Gil Yosipovitch, MD )
Study ID Numbers: 00000046
Study First Received: June 9, 2008
Last Updated: June 10, 2008
ClinicalTrials.gov Identifier: NCT00696397  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Dyssomnias
Sleep Disorders
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009