UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized control trial of individual brief sleep hygiene education for sleep and productivity in the workplace
Title of the study (Brief title)	Intervention study of individual brief sleep hygiene education
Region	Japan

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

Objectives
Narrative objectives1	effectiveness measurement for sleep hygiene education
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Pittsburgh Sleep Quality Index
Key secondary outcomes	work productivity

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	individual brief sleep hygiene education (30 minutes)
Interventions/Control_2	follow-up by e-mail for 6 weeks
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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	more than 5 points of Pittsburgh Sleep Quality Index
Key exclusion criteria	suspect of sleep apnea syndrome
Target sample size	40

Research contact person
Name of lead principal investigator	Tomohisa Nagata
Organization	University of Occupational and Environmental Health
Division name	Institute of Industrial Ecological Sciences
Address	Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu-city Fukuoka
TEL	093-603-1611
Email	tomohisa@med.uoeh-u.ac.jp

Public contact
Name of contact person	Tomohisa Nagata
Organization	University of Occupational and Environmental Health
Division name	Institute of Industrial Ecological Sciences
Address	Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu-city Fukuoka
TEL	093-603-1611
Homepage URL
Email	tomohisa@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Institute of Industrial Ecological Sciences
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 09 Month 25 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 05 Month 16 Day
Anticipated trial start date	2017 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 25 Day
Last modified on	2017 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033458