Cooling Pillow for Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University
ClinicalTrials.gov Identifier:
NCT01132651
First received: May 26, 2010
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention
Atopic Dermatitis
Eczema
Other: Current standard eczema treatment and standard pillow at night
Other: Chillow cooling pillow

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Novel Use of a Cooling Pillow for Treatment of Severe Hand and Neck Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score [ Time Frame: Baseline and at 2 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and at 2 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 9
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132651

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Dennis West, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT01132651     History of Changes
Other Study ID Numbers: STU 28933
Study First Received: May 26, 2010
Results First Received: July 30, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
eczema
itch
pruritus
head
neck

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014