An interventional study of Current standard eczema treatment and standard pillow at night and Chillow cooling pillow in Atopic Dermatitis and Eczema, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-05.
Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care
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).
1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's enrollment of 9 is below the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks.
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.
Time frame: Baseline and at 2 weeks
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.
Time frame: Baseline and at 2 weeks
| Milestone | Chillow (Cooling Pillow) | Control (Normal Pillow) |
|---|---|---|
| Started | 4 | 5 |
| Completed | 3 | 4 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
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.
| units on a scale | Chillow (Cooling Pillow) | Control (Normal Pillow) |
|---|---|---|
| Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score | -1 (-2 to 0) | -2 (-3 to 2) |
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.
| units on a scale | Chillow (Cooling Pillow) | Control (Normal Pillow) |
|---|---|---|
| Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score | -1 (-1 to -1) | -1 (-2 to 0) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chillow (Cooling Pillow) | — | 0/4 (0%) | 0/4 (0%) |
| Control (Normal Pillow) | — | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Chillow (Cooling Pillow) | Control (Normal Pillow) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 5 | 9 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Chillow (Cooling Pillow) | Control (Normal Pillow) | Total |
|---|---|---|---|
| Mean | 35 ± 10.3 | 34 ± 13.5 | 34.4 ± 12.2 |
| Sex: Female, Male(Participants) | Chillow (Cooling Pillow) | Control (Normal Pillow) | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 2 | 3 | 5 |
| Region of Enrollment(participants) | Chillow (Cooling Pillow) | Control (Normal Pillow) | Total |
|---|---|---|---|
| United States | 4 | 5 | 9 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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