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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
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Atopic Dermatitis
Eczema
Interventions Other: Current standard eczema treatment and standard pillow at night
Other: Chillow cooling pillow
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chillow (Cooling Pillow) Control (Normal Pillow)
Hide Arm/Group Description This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night. This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
Period Title: Overall Study
Started 4 5
Completed 3 4
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Chillow (Cooling Pillow) Control (Normal Pillow) Total
Hide Arm/Group Description This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night. This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night. Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
5
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
35  (10.3) 34  (13.5) 34.4  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
2
  50.0%
2
  40.0%
4
  44.4%
Male
2
  50.0%
3
  60.0%
5
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 9 participants
4 5 9
1.Primary Outcome
Title Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score
Hide Description

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.

Time Frame Baseline and at 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chillow (Cooling Pillow) Control (Normal Pillow)
Hide Arm/Group Description:
This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
Overall Number of Participants Analyzed 3 4
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-1
(-2 to 0)
-2
(-3 to 2)
2.Secondary Outcome
Title Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score
Hide Description 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.
Time Frame Baseline and at 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chillow (Cooling Pillow) Control (Normal Pillow)
Hide Arm/Group Description:
This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
Overall Number of Participants Analyzed 3 4
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-1
(-1 to -1)
-1
(-2 to 0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chillow (Cooling Pillow) Control (Normal Pillow)
Hide Arm/Group Description This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night. This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
All-Cause Mortality
Chillow (Cooling Pillow) Control (Normal Pillow)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chillow (Cooling Pillow) Control (Normal Pillow)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chillow (Cooling Pillow) Control (Normal Pillow)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mandy Browning
Organization: Northwestern University
Phone: 312-695-6829
Responsible Party: Dennis West, Northwestern University
ClinicalTrials.gov Identifier: NCT01132651     History of Changes
Other Study ID Numbers: STU 28933
First Submitted: May 26, 2010
First Posted: May 28, 2010
Results First Submitted: July 30, 2012
Results First Posted: January 16, 2013
Last Update Posted: January 5, 2015