Cooling Pillow for Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to see if using a cooling pillow at night will help sleep quality in people with atopic dermatitis (AD).

Official Title
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Novel Use of a Cooling Pillow for Treatment of Severe Hand and Neck Atopic Dermatitis

Conditions
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Atopic Dermatitis, Eczema

Intervention / Treatment
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* Other: Current standard eczema treatment and standard pillow at night
* Other: Chillow cooling pillow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of AD by dermatologist AD located on the head and neck Investigator Global Assessment (IGA)score >3 at time of enrollment Able to read, write, and understand study materials Age 18 or older Exclusion Criteria: Concurrent non-AD skin disease on the head and neck Active skin infection on the head and neck, or conditions that may interfere with evaluation of the skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chillow cooling pillow<br>This group of subjects will follow their current eczema regimen with the addition of using the cooling pillow at night to sleep on. | Other: Chillow cooling pillow<br>* Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks.<br>|
| Placebo Comparator: Standard of care (regular pillow at night)<br>This group of subjects will serve as the control group following a their current eczema care regimen, including sleeping on their normal pillow. | Other: Current standard eczema treatment and standard pillow at night<br>* Subjects will continue with their current eczema care and use their normal pillow at night.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score | The PSQI is a clinical survey used to measure sleep quality. Seven components related to sleep quality are scored: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale of 0 to 3. A score of 0 is associated with better sleep quality and a score of 3 is associated with worse sleep quality. The seven component scores are summed to achieve a total PSQI score. The total PSQI score has a range of 0-21. A score of 0 is associated with better sleep quality and a score of 21 is associated with worse sleep quality. Buysse,D.J., Reynolds,C.F., Monk,T.H., Berman,S.R., & Kupfer,D.J. (1989). The Pittsburgh Sleep Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry Research, 28(2), 193-213. | Baseline and at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score | The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD. | Baseline and at 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eczema, itch, pruritus, head, neck