Cooling Pillow for Atopic Dermatitis
|ClinicalTrials.gov Identifier: NCT01132651|
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : January 16, 2013
Last Update Posted : January 5, 2015
|Condition or disease||Intervention/treatment|
|Atopic Dermatitis Eczema||Other: Current standard eczema treatment and standard pillow at night Other: Chillow cooling pillow|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Novel Use of a Cooling Pillow for Treatment of Severe Hand and Neck Atopic Dermatitis|
|Study Start Date :||May 2010|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
Experimental: 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.
Other: Chillow cooling pillow
Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks.
Placebo Comparator: Standard of care (regular 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.
Other: Current standard eczema treatment and standard pillow at night
Subjects will continue with their current eczema care and use their normal pillow at night.
- Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score [ Time Frame: 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.
- Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132651
|United States, Illinois|
|Northwestern University Feinberg School of Medicine, Department of Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Dennis West, PhD||Northwestern University|