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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043681
Receipt No. R000049878
Scientific Title Effects of simulated long working hours and sleep restriction on physiological and psychological responses in healthy middle-aged men: An experimental study
Date of disclosure of the study information 2021/03/19
Last modified on 2021/03/19

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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

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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