UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032951 |
|---|---|
| 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 |
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Basic information
Public title
Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders
Acronym
Double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders
Scientific Title
Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders
Scientific Title:Acronym
Double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders
Region
| Japan | Asia(except Japan) |
Condition
Condition
Insomnia disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy at 8 weeks from the start of treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of Athens Insomnia Scale at 8 weeks from the start of treatment
Key secondary outcomes
KSS, QIDS, CGI-I, medication after completion of clinical trial
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
non-medication therapy for 8weeks by application
Interventions/Control_2
part of non medication therapy for 8weeks by application
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Insomnia disorder (ICSD-3).
2. Patients who can understand Japanese.
3. Patient who has smartphone.
Key exclusion criteria
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.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Ueno |
Organization
Sustainable Medicine,Inc
Division name
CEO
Zip code
Address
3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo Japan
TEL
03-3527-3593
taro.ueno@susmed.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Kojima |
Organization
Sustainable Medicine,Inc
Division name
Regulatory and Clinical research
Zip code
Address
3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo Japan
TEL
03-3527-3593
Homepage URL
takayuki.kojima@susmed.co.jp
Sponsor or person
Institute
Sustainable Medicine,Inc
Institute
Department
Personal name
Funding Source
Organization
Sustainable Medicine,Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 06 | Month | 11 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 11 | Day |
Last modified on
| 2020 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037564
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
