- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696397
Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology
March 14, 2017 updated by: Wake Forest University
Sleep Disturbance in Atopic Dermatitis: A Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Winston Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adult men and women between 18 and 50 years of age with atopic dermatitis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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A
adult men and women between 18 and 50 years of age with atopic dermatitis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
June 9, 2008
First Submitted That Met QC Criteria
June 10, 2008
First Posted (Estimate)
June 12, 2008
Study Record Updates
Last Update Posted (Actual)
March 16, 2017
Last Update Submitted That Met QC Criteria
March 14, 2017
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00000046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
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Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
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Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
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ShaperonRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of ScalpUnited States
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
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AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
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SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
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SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
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Regeneron PharmaceuticalsSanofiRecruitingModerate-to-Severe Atopic Dermatitis | Atopic EczemaUnited States
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Hadassah Medical OrganizationUnknownATOPIC DERMATITIS