UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039404
Receipt number 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 11:25:43

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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