UMIN-CTR Clinical Trial

Basic information
Public title	Effects of simulated long working hours and sleep restriction on physiological and psychological responses in healthy middle-aged men: An experimental study
Acronym	Effects of simulated long working hours and sleep restriction on physiological and psychological responses in healthy middle-aged men: An experimental study
Scientific Title	Effects of simulated long working hours and sleep restriction on physiological and psychological responses in healthy middle-aged men: An experimental study
Scientific Title:Acronym	Effects of simulated long working hours and sleep restriction on physiological and psychological responses in healthy middle-aged men: An experimental study
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of long working hours after short sleep duration on physiological and psychological responses in an experimental laboratory
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	hemodynamic responses, psychological responses, and salivary hormone were measured during simulated long working hours.
Key secondary outcomes	hemodynamic responses (systolic blood pressure, diastolic blood pressure, mean arterial pressure, stroke volume, heart rate, cardiac output, and total peripheral resistance), psychological responses (sleepiness, fatigue, stress, motivation, and depression), and salivary hormone (cortisol and C-reactive protein)

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	40 years-old <=
Age-upper limit	59 years-old >=
Gender	Male
Key inclusion criteria	normotensive male adults. Ex- or nonsmoker. Usual sleep duration is 6 hours 30 minutes to 7 hours 30 minutes.
Key exclusion criteria	Previous history: cardiac disease, diabetes, asthma, cerebral stroke, chronic liver disorder, back problems, and mental disorders.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Ikeda
Organization	National Institute of Occupational Safety and Health, Japan
Division name	Ergonomics Research Group
Zip code	214-8585
Address	Nagao 6-21-1, Tama-ku, Kawasaki, Kanagawa 214-8585, Japan
TEL	0448656111
Email	ikedah@h.jniosh.johas.go.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Ikeda
Organization	National Institute of Occupational Safety and Health, Japan
Division name	Ergonomics Research Group
Zip code	214-8585
Address	Nagao 6-21-1, Tama-ku, Kawasaki, Kanagawa 214-8585, Japan
TEL	0448656111
Homepage URL
Email	ikedah@h.jniosh.johas.go.jp

Sponsor
Institute	National Institute of Occupational Safety and Health, Japan
Institute
Department

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

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

IRB Contact (For public release)
Organization	Institutional Review Board of National Institute of Occupational Safety and Health, Japan
Address	Nagao 6-21-1, Tama-Ku, Kawasaki 214-8585 Japan
Tel	044-865-6111
Email	ikedah@h.jniosh.johas.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	2021 Year 03 Month 19 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	20
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	Completed
Date of protocol fixation	2018 Year 06 Month 15 Day
Date of IRB	2018 Year 07 Month 31 Day
Anticipated trial start date	2019 Year 01 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	20 male participants took part in a crossover design experiment consisting of two conditions: normal (7h) sleep and short (5h) sleep. Participants participated in simulated long working hours (13h), which consisted of 12 task sessions. Physiological and psychological responses were measured in each session.

Management information
Registered date	2021 Year 03 Month 19 Day
Last modified on	2021 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049878