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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis West, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chillow (Cooling Pillow) | This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night. |
| FG001 | Control (Normal Pillow) | This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chillow (Cooling Pillow) | This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night. |
| BG001 | Control (Normal Pillow) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and at 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chillow (Cooling Pillow) | This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mandy Browning | Northwestern University | 312-695-6829 | mandybrowning2015@u.northwestern.edu |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Chillow cooling pillow | Other | Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks. |
|
| Baseline and at 2 weeks |
This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Chillow (Cooling Pillow) |
This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night. |
| OG001 | Control (Normal Pillow) | This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and at 2 weeks |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Control (Normal Pillow) | This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night. | 0 | 5 | 0 | 5 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |