Cooling Pillow for Atopic Dermatitis

NCT01132651 | Completed Results DMC

• 1 other identifier: STU 28933
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Dermatitis; Eczema

Keywords

eczema; itch; pruritus; head; neck

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and at 2 weeks

Secondary Outcomes (1)

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

  Baseline and at 2 weeks

Study Arms (2)

Chillow cooling pillow

EXPERIMENTAL

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

Standard of care (regular pillow at night)

PLACEBO COMPARATOR

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

Interventions

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.

Standard of care (regular 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.

Chillow cooling pillow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mandy Browning
• Organization: Northwestern University

mandybrowning2015@u.northwestern.edu

312-695-6829

Study Officials

• Dennis West, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology and Pediatrics

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 5, 2015
• Results First Posted: January 16, 2013

Record last verified: 2014-12

Locations

US (1)