UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2020 Year 10 Month 22 Day
Date of IRB	2020 Year 11 Month 17 Day
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	2022 Year 11 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048273