Unique ID issued by UMIN | UMIN000032951 |
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Receipt number | R000037564 |
Scientific Title | Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders |
Date of disclosure of the study information | 2018/06/11 |
Last modified on | 2020/09/01 17:33:59 |
Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders
Double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders
Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders
Double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders
Japan | Asia(except Japan) |
Insomnia disorder
Psychiatry |
Others
NO
Evaluation of efficacy at 8 weeks from the start of treatment
Safety
Evaluation of Athens Insomnia Scale at 8 weeks from the start of treatment
KSS, QIDS, CGI-I, medication after completion of clinical trial
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Device,equipment |
non-medication therapy for 8weeks by application
part of non medication therapy for 8weeks by application
20 | years-old | <= |
Not applicable |
Male and Female
1. Insomnia disorder (ICSD-3).
2. Patients who can understand Japanese.
3. Patient who has smartphone.
1. Patients with Athens Insomnia Scale (AIS) at the beginning of the trial less than 9 points.
2. Patients who have experienced drug treatment for insomnia within the past 14 days.
3. Patients without a sleeping diary since 7 days from the start of the trial.
4. Patients suspected or suffering from the following diseases.
Mental illness
Sleep apnea syndrome
Sleep-related movement disorder
Central hypersomnia
Accompanying sleep
Circadian rhythm disturbance
alcoholism
drug addiction
cancer
immune disease
5. Pregnant women, lactating women
6. Patients who are engaged in jobs requiring driving such as automobiles or motorbikes or jobs involving danger or scheduled to participate during the trial participation period.
110
1st name | |
Middle name | |
Last name | Taro Ueno |
Sustainable Medicine,Inc
CEO
3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo Japan
03-3527-3593
taro.ueno@susmed.co.jp
1st name | |
Middle name | |
Last name | Takayuki Kojima |
Sustainable Medicine,Inc
Regulatory and Clinical research
3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo Japan
03-3527-3593
takayuki.kojima@susmed.co.jp
Sustainable Medicine,Inc
Sustainable Medicine,Inc
Profit organization
NO
2018 | Year | 06 | Month | 11 | Day |
Unpublished
Completed
2018 | Year | 05 | Month | 25 | Day |
2018 | Year | 06 | Month | 11 | Day |
2018 | Year | 06 | Month | 12 | Day |
2018 | Year | 09 | Month | 08 | Day |
2018 | Year | 06 | Month | 11 | Day |
2020 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037564
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Research case data specifications | |
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Research case data | |
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