Trial Outcomes & Findings for Cooling Pillow for Atopic Dermatitis (NCT NCT01132651)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Baseline and at 2 weeks

Results posted on

2015-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Chillow (Cooling Pillow) This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.	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.
Overall Study STARTED	4	5
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Chillow (Cooling Pillow) This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.	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.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Cooling Pillow for Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chillow (Cooling Pillow) n=4 Participants This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.	Control (Normal Pillow) n=5 Participants This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 10.3 • n=5 Participants	34 years STANDARD_DEVIATION 13.5 • n=7 Participants	34.4 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Chillow (Cooling Pillow) n=3 Participants This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.	Control (Normal Pillow) n=4 Participants This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score	-1 units on a scale Interval -2.0 to 0.0	-2 units on a scale Interval -3.0 to 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Chillow (Cooling Pillow) n=3 Participants This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.	Control (Normal Pillow) n=4 Participants This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score	-1 units on a scale Interval -1.0 to -1.0	-1 units on a scale Interval -2.0 to 0.0

Adverse Events

Chillow (Cooling Pillow)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (Normal Pillow)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mandy Browning

Northwestern University

Phone: 312-695-6829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place