UMIN-CTR Clinical Trial

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
Email	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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037564