UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043046 |
|---|---|
| Receipt number | R000049143 |
| Scientific Title | Effects of sleep deprivation on cardiovascular response during exercise |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2022/06/29 14:38:03 |
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Basic information
Public title
Effects of sleep deprivation on cardiovascular response during exercise
Acronym
Effects of sleep deprivation on cardiovascular response during exercise
Scientific Title
Effects of sleep deprivation on cardiovascular response during exercise
Scientific Title:Acronym
Effects of sleep deprivation on cardiovascular response during exercise
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of sleep deprivation on cardiovascular system during exercise
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure response to exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sleep deprivation
Interventions/Control_2
Sleep deprivation + snooze
Interventions/Control_3
Sleep deprivation + physical activity
Interventions/Control_4
No sleep deprivation
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy men with no special diseases who do not feel sleep deprived on a daily basis.
Key exclusion criteria
Men who have a disease or feel sleep deprived.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Hotta |
Organization
Chubu University
Division name
Department of Lifelong Sports for Health College of Life and Health Sciences
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
TEL
0568-51-9667
horinori@isc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | Hotta |
| Last name | Hotta |
Organization
Chubu University
Division name
Department of Lifelong Sports for Health College of Life and Health Sciences
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
TEL
0568-51-9667
Homepage URL
horinori@isc.chubu.ac.jp
Sponsor or person
Institute
Chubu University
Institute
Department
Personal name
Funding Source
Organization
Chubu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The KAITEKI Institute, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Chubu University
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
Tel
0568-51-4424
gakuji@office.chubu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049143
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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