Atopic DermatitisNCT01132651
Cooling Pillow for Atopic Dermatitis
A study testing Current standard eczema treatment and standard pillow at night and Chillow cooling pillow in people with Atopic Dermatitis and Eczema, run by Northwestern University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Current standard eczema treatment and standard pillow at night and Chillow cooling pillow
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Novel Use of a Cooling Pillow for Treatment of Severe Hand and Neck Atopic Dermatitis
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).
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Current standard eczema treatment and standard pillow at night, Chillow cooling pillow
- Keywords
- eczema, itch, pruritus, head, neck
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current standard eczema treatment and standard pillow at nightOther
Subjects will continue with their current eczema care and use their normal pillow at night.
Chillow cooling pillowOther
Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chillow cooling pillow |
| 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. Receives: Other: Current standard eczema treatment and standard pillow at night |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 2 weeks
Secondary outcomes (1)
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.
Measured: Baseline and at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis West, Northwestern University
- Investigators
- Dennis West, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132651
- Sponsor's protocol ID
- STU 28933
- Status last verified
- Dec 2014
- First submitted
- 26 May 2010
- Last updated
- 5 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Use of a Cooling Pillow for Treatment of Severe Hand and Neck Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01132651
- Acronym / sponsor ID
- STU 28933
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- eczema, itch, pruritus, head, neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Posted 16 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chillow cooling pillow | Experimental | Other: Chillow cooling pillowThis 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 | Other: Current standard eczema treatment and standard pillow at nightThis group of subjects will serve as the control group following a their current eczema care regimen, including sleeping on their normal pillow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current standard eczema treatment and standard pillow at nightSubjects will continue with their current eczema care and use their normal pillow at night. | Other | Standard of care (regular pillow at night) |
| Chillow cooling pillowSubjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks. | Other | Chillow cooling pillow |
Primary outcome
Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score
Time frame: 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.
1 secondary outcome
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score
Time frame: Baseline and at 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis West, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current standard eczema treatment and standard pillow at night and Chillow cooling pillow in people with Atopic Dermatitis and Eczema, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score (time frame: Baseline and at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.