UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042336 |
|---|---|
| Receipt number | 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 | 2022/11/07 18:53:06 |
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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
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
m-take@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048273
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
