Cooling Pillow for Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis; Eczema
• Interventions: Other: Current standard eczema treatment and standard pillow at night; Other: Chillow cooling pillow

• Registration Number: NCT01132651
• Lead Sponsor: Northwestern University

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-28
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-07-30
• Results First Submitted QC: 2012-12-10
• Results First Posted: 2013-01-16
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2015-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care (regular pillow at night)	Current standard eczema treatment and standard pillow at night	This group of subjects will serve as the control group following a their current eczema care regimen, including sleeping on their normal pillow.
Chillow cooling pillow	Chillow cooling pillow	This group of subjects will follow their current eczema regimen with the addition of using the cooling pillow at night to sleep on.

Primary Outcome Measures

Name	Time	Method
Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score	Baseline and at 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score	Baseline and at 2 weeks	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.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States