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Completed

NCT Number: NCT01132651

Cooling Pillow for Atopic Dermatitis

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).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Current standard eczema treatment and standard pillow at night

Other

Subjects will continue with their current eczema care and use their normal pillow at night.

Chillow cooling pillow

Other

Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Novel Use of a Cooling Pillow for Treatment of Severe Hand and Neck Atopic Dermatitis

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 28, 2010
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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