UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054983 |
|---|---|
| Receipt number | R000062625 |
| Scientific Title | Effect of two 30-minute naps during the night - a randomized, crossover, controlled trial |
| Date of disclosure of the study information | 2024/07/17 |
| Last modified on | 2024/07/16 20:17:02 |
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Basic information
Public title
Effect of two 30-minute naps during the night - a randomized, crossover, controlled trial
Acronym
Effect of two 30-minute naps during the night - a randomized, crossover, controlled trial
Scientific Title
Effect of two 30-minute naps during the night - a randomized, crossover, controlled trial
Scientific Title:Acronym
Effect of two 30-minute naps during the night - a randomized, crossover, controlled trial
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate performance and subjective sleepiness after two 30-minute naps during the night.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A psychomotor arousal task (PVT) was used to assess neurobehavioral function. PVT was measured every hour from 16:00-09:30.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Take a 30-minute nap during the night.
Interventions/Control_2
Take two 30-minute naps during the night.
Interventions/Control_3
Not sleeping during the night.
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
| 23 | years-old | >= |
Gender
Female
Key inclusion criteria
There are no abnormalities found on the medical examination.
Key exclusion criteria
The participants were not obvious morning type or evening type on the "Morningness-Eveningness Questionnaire".
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Sanae |
| Middle name | |
| Last name | Oriyama |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Division of Nursing Science
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5355
oriyama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Sanae |
| Middle name | |
| Last name | Oriyama |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Division of Nursing Science
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5355
Homepage URL
oriyama@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima, Japan
Tel
082-257-1551
iryo-sinsa@office.hiroshima-u.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
| 2024 | Year | 07 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062625
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
