Atopic Dermatitis, Eczema
Conditions
Keywords
eczema, itch, pruritus, head, neck
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).
Interventions
OTHERCurrent standard eczema treatment and standard pillow at night
Subjects will continue with their current eczema care and use their normal pillow at night.
OTHERChillow cooling pillow
Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chillow (Cooling Pillow) This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night. | 4 |
| 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. | 5 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Control (Normal Pillow) | Chillow (Cooling Pillow) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 13.5 | 35 years STANDARD_DEVIATION 10.3 | 34.4 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 5 participants | 4 participants | 9 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
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.
Time frame: Baseline and at 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chillow (Cooling Pillow) | Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score | -1 units on a scale |
| Control (Normal Pillow) | Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score | -2 units on a scale |
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.
Time frame: Baseline and at 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chillow (Cooling Pillow) | Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score | -1 units on a scale |
| Control (Normal Pillow) | Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score | -1 units on a scale |