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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026990
Receipt No. R000030947
Scientific Title Epidemiological study on scratching duration while asleep and pruritus: a ResearchKit study
Date of disclosure of the study information 2017/04/13
Last modified on 2018/04/15

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Basic information
Public title Epidemiological study on scratching duration while asleep and pruritus: a ResearchKit study
Acronym ResearchKit study on pruritus
Scientific Title Epidemiological study on scratching duration while asleep and pruritus: a ResearchKit study
Scientific Title:Acronym ResearchKit study on pruritus
Region
Japan Asia(except Japan) North America
South America Australia Europe
Africa

Condition
Condition no disease-related limitation
Classification by specialty
Dermatology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation on factors affecting or correlated to scratching time during sleep
Basic objectives2 Others
Basic objectives -Others Investigation on correlation of scratching time during sleep with self-evaluated itch severity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Answers to questionnaires and scratching time measured by Apple Watch
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who possess both iPhone and Apple Watch and give informed consent will participate. If the subject is a child or has no capability of giving informed consent, representatives such as family members will give informed consent.
Key exclusion criteria Those who cannot wear Apple Watch during sleep should not participate.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko IKOMA
Organization Nestle Skin Health
Division name SHIELD Asia Pacific
Zip code
Address 34th floor, 8-17-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL +81-3-5937-3850
Email info@nestleskinhealth.com

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko IKOMA
Organization Nestle Skin Health
Division name SHIELD Asia Pacific
Zip code
Address 34th Floor, 8-17-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL +81-3-5937-3850
Homepage URL
Email info@nestleskinhealth.com

Sponsor
Institute Nestle Skin Health
Institute
Department

Funding Source
Organization Nestle Skin Health
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Epidemiological study using ResearchKit app

Management information
Registered date
2017 Year 04 Month 13 Day
Last modified on
2018 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030947

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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