UMIN-CTR Clinical Trial

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