UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047082 |
|---|---|
| Receipt number | R000053708 |
| Scientific Title | The effects of somatosensory stimulation with different vibration frequencies on sleep and athletic performance. |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2023/03/07 13:56:41 |
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Basic information
Public title
The effects of somatosensory stimulation with different vibration frequencies on sleep and athletic performance.
Acronym
The effects of somatosensory stimulation with different vibration frequencies on sleep and athletic performance.
Scientific Title
The effects of somatosensory stimulation with different vibration frequencies on sleep and athletic performance.
Scientific Title:Acronym
The effects of somatosensory stimulation with different vibration frequencies on sleep and athletic performance.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effects of somatosensory stimulation with vibration different frequencies on sleep and athletic performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index
Key secondary outcomes
Subjective feeling of fatigue score
Insomnia Severity Index
Sprint time
vertical jump test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
High frequency vibration stimulation
Interventions/Control_2
Middle frequency vibration stimulation
Interventions/Control_3
Low frequency vibration stimulation
Interventions/Control_4
Control
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Key exclusion criteria
1)Subjects with sleeping pills
2)Subjects with musculoskeletal disorder
3)Subjects whom are recognized as inadequate subjects by the experimenters.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kouichi |
| Middle name | |
| Last name | Takamoto |
Organization
University of East Asia
Division name
Department of sport and Health Sciences, Faculty of human Sciences
Zip code
751-8503
Address
2-1 Ichinomiya Gakuencho, Shimonoseki City, Yamaguchi Prefecture
TEL
083-256-1111
ktakamo@toua-u.ac.jp
Public contact
Name of contact person
| 1st name | Kouichi |
| Middle name | |
| Last name | Takamoto |
Organization
University of East Asia
Division name
Department of sport and health Science, Faculty of Human Sciences
Zip code
751-8503
Address
2-1 Ichinomiya Gakuencho, Shimonoseki City, Yamaguchi Prefecture
TEL
083-256-1111
Homepage URL
ktakamo@toua-u.ac.jp
Sponsor or person
Institute
University of East Asia
Institute
Department
Personal name
Funding Source
Organization
Dream factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Toyama
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of East Asia University
Address
2-1 Ichinomiya Gakuencho, Shimonoseki City, Yamaguchi Prefecture
Tel
083-256-1111
kyomushitsu@toua-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
東亜大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 04 | 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
| 2022 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | 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
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053708
