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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032951
Receipt No. R000037564
Official scientific title of the study 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 2018/12/10

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Basic information
Official scientific title of the study Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yue in patients with insomnia disorders
Title of the study (Brief title) 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 Taro Ueno
Organization Sustainable Medicine,Inc
Division name CEO
Address 3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo Japan
TEL 03-3527-3593
Email taro.ueno@susmed.co.jp

Public contact
Name of contact person Takayuki Kojima
Organization Sustainable Medicine,Inc
Division name Regulatory and Clinical research
Address 3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo Japan
TEL 03-3527-3593
Homepage URL
Email takayuki.kojima@susmed.co.jp

Sponsor
Institute Sustainable Medicine,Inc
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 05 Month 25 Day
Anticipated trial start date
2018 Year 06 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 11 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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