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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039404
Receipt No. R000044925
Scientific Title A randomized controlled trial of the effects of a remote sleep intervention program in workplaces on sleep improvement and work productivity
Date of disclosure of the study information 2020/02/06
Last modified on 2020/02/06

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Basic information
Public title A randomized controlled trial of the effects of a remote sleep intervention program in workplaces on sleep improvement and work productivity
Acronym A randomized controlled trial of the effect of a remote sleep intervention program on sleep improvement
Scientific Title A randomized controlled trial of the effects of a remote sleep intervention program in workplaces on sleep improvement and work productivity
Scientific Title:Acronym A randomized controlled trial of the effect of a remote sleep intervention program on sleep improvement
Region
Japan

Condition
Condition Insomnia
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to conduct a sleep intervention program in the workplace to evaluate sleep improvement and its effect on work productivity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Pittsburgh Sleep Questionnaire Scores, Sleep Efficiency, Latency, Sleepiness, Athens Insomnia Scale Score(Evaluated by questionnaire survey 12 weeks after baseline)
Key secondary outcomes Insomnia severity index score, Presenteeism(WFun score)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Sleep hygiene education (1 hour)
Sleep record
Viewing information about sleep hygiene (e-learning)
Individual guidance by professionals (2 weeks after the start of the intervention, once only)
Interventions/Control_2 Sleep hygiene education (1 hour)
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
65 years-old >=
Gender Male and Female
Key inclusion criteria A person with a score of 6 or more (highly likely to have insomnia) on the Athens Insomnia Scale (0-24 points)
Key exclusion criteria People taking oral sleep medications (including over-the-counter medications)
Persons who are referred to a medical institution for mental illness, restless leg syndrome, periodic limb movement disorder, narcolepsy, parasomnia
People who have been treated or have been treated for sleep apnea syndrome in the past or present, or who are highly suspicious, such as being told by others that they have apnea during sleep
Heavy drinker
Shift worker
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Tomohisa
Middle name
Last name Nagata
Organization University of occupational and environmental health, Japan
Division name Institute of Industrial Ecological Sciences
Zip code 807-8555
Address 1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
TEL +81-93-603-1611
Email tomohisa@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name Tomohisa
Middle name
Last name Nagata
Organization University of occupational and environmental health, Japan
Division name Institute of Industrial Ecological Sciences
Zip code 807-8555
Address 1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
TEL +81-93-603-1611
Homepage URL
Email tomohisa@med.uoeh-u.ac.jp

Sponsor
Institute Dept. of Occupational Health Practice and Management, Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization Collaboration Health Study Group
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 University of occupational and environmental health, Japan
Address 1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
Tel +81-93-603-1611
Email tomohisa@med.uoeh-u.ac.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 産業医科大学(福岡県)

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 06 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 Enrolling by invitation
Date of protocol fixation
2019 Year 12 Month 10 Day
Date of IRB
2020 Year 01 Month 10 Day
Anticipated trial start date
2020 Year 01 Month 15 Day
Last follow-up date
2020 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 06 Day
Last modified on
2020 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044925

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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