UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032004 |
|---|---|
| Receipt number | R000036461 |
| Scientific Title | Development of effective feedback system for improving sleep habits using objective sleep parameters |
| Date of disclosure of the study information | 2018/03/30 |
| Last modified on | 2019/07/23 11:37:31 |
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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)
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
s-kita@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036461
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
