UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012506 |
|---|---|
| Receipt number | R000013276 |
| Scientific Title | The effect of sleep shortage on energy metabolism and physiological functions |
| Date of disclosure of the study information | 2013/12/06 |
| Last modified on | 2013/12/06 13:31:56 |
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Basic information
Public title
The effect of sleep shortage on energy metabolism and physiological functions
Acronym
The effect of sleep shortage on energy metabolism and physiological functions
Scientific Title
The effect of sleep shortage on energy metabolism and physiological functions
Scientific Title:Acronym
The effect of sleep shortage on energy metabolism and physiological functions
Region
| Japan |
Condition
Condition
diabetes, insomnia, depression
Classification by specialty
| Medicine in general | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine how sleep restriction affect physiological functions such as sleep EEG, energy expenditure, body temperature and endocrine system.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We examine Sleep EEG, energy expenditure, body temperature, hormone level (blood and urine sampling), cognitive function, subjective evaluation (sleepiness, appetite) after 3 days sleep restriction and after recovery sleep.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
continuous 3 nights sleep restriction(3.5h) following 1 night recovery sleep(7h), washout period, 4 nights normal sleep(7h)
Interventions/Control_2
4 nights normal sleep(7h), washout period, continuous 3 nights sleep restriction(3.5h) following 1 night recovery sleep(7h)
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
healthy both physically and mentally men in their 20s
Key exclusion criteria
person have sleep disorders, evaluated morning or night type by morningness-eveningness questionnaire
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sunao Uchida |
Organization
Waseda University
Division name
Faculty of sport sciences
Zip code
Address
2-579-15 Mikajima Tokorozawa, Saitama
TEL
04-2947-6771
sunao@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sunao Uchida |
Organization
Waseda University
Division name
Faculty of sport sciences
Zip code
Address
2-579-15 Mikajima Tokorozawa, Saitama
TEL
04-2947-6771
Homepage URL
sunao@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 06 | Day |
Last modified on
| 2013 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013276
