UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046380 |
|---|---|
| Receipt number | R000052925 |
| Scientific Title | Effects of rocking seat on nap |
| Date of disclosure of the study information | 2021/12/16 |
| Last modified on | 2024/01/06 17:16:36 |
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Basic information
Public title
Effects of rocking seat on nap
Acronym
Effects of rocking seat on nap
Scientific Title
Effects of rocking seat on nap
Scientific Title:Acronym
Effects of rocking seat on nap
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand effects of rocking seat on nap
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Total sleep time, sleep efficiency, sleep latency, the amount and power of deep (slow-wave) sleep, and the amount and power of sleep spindles
Key secondary outcomes
1. Cognitive performance
2. Subjective sleepiness/fatigue
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
A. condition 1 (sham)
The experiment sequence (A, B, C, D) is ordered by the Latin square design.
Interventions/Control_2
B. condition 2 (rocking stimulation)
The experiment sequence (A, B, C, D) is ordered by the Latin square design.
Interventions/Control_3
C. condition 3 (rocking stimulation)
The experiment sequence (A, B, C, D) is ordered by the Latin square design.
Interventions/Control_4
D. condition 4 (rocking stimulation)
The experiment sequence (A, B, C, D) is ordered by the Latin square design.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Having no difficulty in filling out Japanese explanatory documents, consent forms, and survey forms
2. No claustrophobia and being able to stay in the examination room on the 5th floor of the Innovation Medical Research Institute, University of Tsukuba, or the mobile sleep lab
3. Having no hearing problems in daily life
4. Currently having no symptoms or no history of sleep disorder
Key exclusion criteria
1. Irregular lifestyle (A guideline for regular life: 21: 00 ~ 1: 00 going to bed, getting up from 6: 00 ~ 9: 00, sleeping 7 ~ 9 hours)
2. BMI less than 18.5 or over 25
3. Worked night shift (after 22:00) within the last three months
4. Having traveled to a country with a time difference of 3 hours or more within the last three months
5. Drink alcohol regularly (at least 40 g of pure alcohol [approximate: 2 cans of beer] twice a week or more)
6. Having a smoking habit
7. Daily caffeine intake of 300 mg or more (approximate: 5 cups of 150 mL coffee)
8. Morningness-Eveningness Questionnaire (MEQ) score 30 points or less or 70 points or above
9. Pittsburgh Sleep Questionnaire Index (PSQI) scores more than 5.5
10. Motion Sickness Susceptibility Questionnaire Short-Form (MSSQ-Short) score of 19 or higher
11. Claustrophobia
12. Pregnant or its possibility
13. Lactation
14. Those who have a disease that may change suddenly or have a history
15. Those who have been treated for mental illness or sleep disorders, those who have symptoms that are currently being treated
16. Subject judged by the investigator to be inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-8550
Address
Innovation Medical Research Institute 502, 1-2 Kasuga, Tsukuba, Ibaraki
TEL
029-859-1858
abe.takashi.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine (WPI-IIIS)
Zip code
305-8550
Address
Innovation Medical Research Institute 502, 1-2 Kasuga, Tsukuba, Ibaraki
TEL
029-859-1858
Homepage URL
abe.takashi.gp@u.tsukuba.ac.jp
Sponsor or person
Institute
International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
TOYOTA BOSHOKU 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
Ethics Committee of Faculty of Engineering, Information and Systems
Address
Tenoudai 1-1-1, Tsukuba, Ibaraki
Tel
0298535600
sien3@un.tsukuba.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
筑波大学国際統合睡眠医科学研究機構 International Institute for Integrative Sleep Medicine, University of Tsukuba (WPI-IIIS)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2024 | 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 | 12 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052925
