Cooling Pillow for Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis; Eczema

• 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

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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