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Cooling Pillow for Atopic Dermatitis

Primary Purpose

Atopic Dermatitis, Eczema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Current standard eczema treatment and standard pillow at night
Chillow cooling pillow
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atopic Dermatitis focused on measuring eczema, itch, pruritus, head, neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chillow cooling pillow

Standard of care (regular pillow at night)

Arm Description

This group of subjects will follow their current eczema regimen with the addition of using the cooling pillow at night to sleep on.

This group of subjects will serve as the control group following a their current eczema care regimen, including sleeping on their normal pillow.

Outcomes

Primary Outcome Measures

Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score
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

Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score
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.

Full Information

First Posted
May 26, 2010
Last Updated
December 11, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01132651
Brief Title
Cooling Pillow for Atopic Dermatitis
Official Title
Novel Use of a Cooling Pillow for Treatment of Severe Hand and Neck Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema
Keywords
eczema, itch, pruritus, head, neck

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chillow cooling pillow
Arm Type
Experimental
Arm Description
This group of subjects will follow their current eczema regimen with the addition of using the cooling pillow at night to sleep on.
Arm Title
Standard of care (regular pillow at night)
Arm Type
Placebo Comparator
Arm Description
This group of subjects will serve as the control group following a their current eczema care regimen, including sleeping on their normal pillow.
Intervention Type
Other
Intervention Name(s)
Current standard eczema treatment and standard pillow at night
Intervention Description
Subjects will continue with their current eczema care and use their normal pillow at night.
Intervention Type
Other
Intervention Name(s)
Chillow cooling pillow
Intervention Description
Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks.
Primary Outcome Measure Information:
Title
Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score
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
Secondary Outcome Measure Information:
Title
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis West, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Cooling Pillow for Atopic Dermatitis

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