UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043681 |
|---|---|
| Receipt number | 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 17:11:45 |
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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
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
ikedah@h.jniosh.johas.go.jp
Sponsor or person
Institute
National Institute of Occupational Safety and Health, Japan
Institute
Department
Personal name
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
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
Value
https://center6.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 |
