Cooling Pillow for Atopic Dermatitis
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|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||Phase|
|Atopic Dermatitis Eczema||Other: Current standard eczema treatment and standard pillow at night Other: Chillow cooling pillow||Not Applicable|
|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|
|Actual Primary Completion Date :||December 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|