Unique ID issued by UMIN | UMIN000042336 |
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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 |
Evaluation on the impact of itch on sleep by using objective assessment in patients with atopic dermatitis: Exploratory study.
Evaluation on the impact of itch on sleep by using objective assessment in patients with atopic dermatitis: Exploratory study.
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
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
Japan |
atopic dermatitis
Dermatology |
Others
NO
We evaluate the effect of itching during sleep on sleep quality
Safety,Efficacy
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
Observational
20 | years-old | <= |
70 | years-old | >= |
Male and Female
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.
Patients judged by the principal investigator to be inappropriate as research subjects
8
1st name | Motoi |
Middle name | |
Last name | Takenaka |
Nagasaki University Graduate School of Biomedical Sciences
Dermatology
852-8501
1-7-1 Sakamoto, Nagasaki City
0958197333
m-take@nagasaki-u.ac.jp
1st name | Motoi |
Middle name | |
Last name | Takenaka |
Nagasaki University Hospital
Dermatoallergology
852-8501
1-7-1 Sakamoto, Nagasaki City
0958197465
m-take@nagasaki-u.ac.jp
Nagasaki University Graduate School of Biomedical Sciences
Maruho Co., Ltd.
Self funding
Clinical Research Center, Nagasaki University Hospital
1-7-1 Sakamoto, Nagasaki City
0958197726
rinshou7726@umin.ac.jp
NO
2020 | Year | 11 | Month | 10 | Day |
Unpublished
Terminated
2020 | Year | 10 | Month | 22 | Day |
2020 | Year | 11 | Month | 17 | Day |
2020 | Year | 11 | Month | 23 | Day |
2021 | Year | 10 | Month | 31 | Day |
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.
2020 | Year | 11 | Month | 04 | Day |
2022 | Year | 11 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048273
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