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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042336
Receipt No. R000048273
Scientific Title Exploratory clinical study to establish a method for objectively assessing the impact of itch intensity and/or scratching behavior to itch on sleep in patients with atopic dermatitis
Date of disclosure of the study information 2020/11/10
Last modified on 2020/11/04

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Basic information
Public title Evaluation on the impact of itch on sleep by using objective assessment in patients with atopic dermatitis: Exploratory study.
Acronym Evaluation on the impact of itch on sleep by using objective assessment in patients with atopic dermatitis: Exploratory study.
Scientific Title Exploratory clinical study to establish a method for objectively assessing the impact of itch intensity and/or scratching behavior to itch on sleep in patients with atopic dermatitis
Scientific Title:Acronym Exploratory clinical study to establish a method for objectively assessing the impact of itch intensity and/or scratching behavior to itch on sleep in patients with atopic dermatitis
Region
Japan

Condition
Condition atopic dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effect of itching during sleep on sleep quality
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Itching during sleep: Analysis of sleep apnea time and pattern with or without scratch by Itch Tracker
Sleep quality: Pattern analysis results of various parameters obtained from brain waves by Sleep scope
Key secondary outcomes

Base
Study type Observational

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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. AD patients with Eczema Area and Severity Index (EASI) score of 7.1-21.0
2. Itching at night (from about 18:00 to falling asleep) is 4 or more on the Numerical Rating Scale (NRS), which is a self-evaluation tool for itching.
Key exclusion criteria Patients judged by the principal investigator to be inappropriate as research subjects
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Motoi
Middle name
Last name Takenaka
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Dermatology
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki City
TEL 0958197333
Email m-take@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Motoi
Middle name
Last name Takenaka
Organization Nagasaki University Hospital
Division name Dermatoallergology
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki City
TEL 0958197465
Homepage URL
Email m-take@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Maruho Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Clinical Research Center, Nagasaki University Hospital
Address 1-7-1 Sakamoto, Nagasaki City
Tel 0958197726
Email rinshou7726@umin.ac.jp

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
2020 Year 11 Month 10 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 23 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In patients with atopic dermatitis, the scratching time and pattern during sleep are evaluated by Itch Tracker, the quality of sleep by an electroencepnea is evaluated by Sleep scope, and the heart rate during sleep is evaluated by Extraction.

Management information
Registered date
2020 Year 11 Month 04 Day
Last modified on
2020 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048273

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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