Cooling Pillow for Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132651
• Other study ID #: STU 28933
• Status: Completed
• Phase: N/A
• First received: May 26, 2010
• Last updated: December 11, 2014
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline and at 2 weeks	No