UMIN-CTR Clinical Trial

Basic information
Public title	Development of effective feedback system for improving sleep habits using objective sleep parameters
Acronym	Development of feedback system for improving sleep habits
Scientific Title	Development of effective feedback system for improving sleep habits using objective sleep parameters
Scientific Title:Acronym	Development of feedback system for improving sleep habits
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of newly-developed feedback system for improving sleep habits
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Subjective sleep quality 2) Subjective sleep time 3) Subjective sleep latency 4) Subjective wake after sleep onset 5) Subjective irregularity of sleep 6) Subjective social jet lag 7) Objective sleep time 8) Objective sleep latency 9) Objective wake after sleep onset 10) Objective irregularity of sleep 11) Objective social jet lag 12) Subjective tiredness
Key secondary outcomes	1) Continuity of sleep habits (Subjective and objective sleep conditions) 2) Efficacy of feedback 3) Personal factors affecting responsibility

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Daily feedback for improving sleep habits from Web system (4 weeks)
Interventions/Control_2
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants who 1) are under sleep debt conditions 2) intend to improve sleep habits 1) are aged 20-59 years old
Key exclusion criteria	Participants who 1) have trouble using PCs, smartphones, or tablets. 2) are Affected with sleep, physical, or psychiatric disorders or using drugs which may affect sleep 3) have alcohol abuse or binge drinking 4) taking supplements which may affect sleep 5) have history of surgery in the previous 3 months 6) traveled across times zones in the previous 6 months 7) worked night shifts in the previous 6 months
Target sample size	62

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Kitamura
Organization	National Center of Neurology and Psychiatry
Division name	National Institute of Mental Health, Department of psychophysiology
Zip code	1878553
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2712(6266)
Email	s-kita@ncnp.go.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Kitamura
Organization	National Center of Neurology and Psychiatry
Division name	National Institute of Mental Health, Department of psychophysiology
Zip code	187-8553
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2712(6266)
Homepage URL
Email	s-kita@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	SoftBank Commerse & Service Corp.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	SoftBank Commerse & Service Corp., Keio University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of the National Center of Neurology and Psychiatry.
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
Tel	042-341-2712(7828)
Email	ml_rinrijimu@ncnp.go.jp

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 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	63
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	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 02 Day
Date of IRB	2018 Year 03 Month 02 Day
Anticipated trial start date	2018 Year 03 Month 30 Day
Last follow-up date	2018 Year 07 Month 31 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 03 Month 30 Day
Last modified on	2019 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036461