UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048287 |
|---|---|
| Receipt number | R000055026 |
| Scientific Title | Effects of experimental pressure stimuli to the outer ear on the vestibular function |
| Date of disclosure of the study information | 2022/07/05 |
| Last modified on | 2025/01/21 09:13:44 |
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Basic information
Public title
Effects of experimental pressure stimuli to the outer ear on the vestibular function
Acronym
Effects of experimental pressure stimuli to the outer ear on the vestibular function
Scientific Title
Effects of experimental pressure stimuli to the outer ear on the vestibular function
Scientific Title:Acronym
Effects of experimental pressure stimuli to the outer ear on the vestibular function
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of experimental pressure stimuli to the outer ear on the vestibular function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sway of the body using an index of center of pressure (CoP)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Pressure stimuli to the outer ear (-90 hPa to +90 hPa/min)
Interventions/Control_2
Sham stimuli
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer (University student)
Key exclusion criteria
Having fever (37.3 degree celsius)
Having pain in the body
Having medication at the time of experiments
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Taguchi |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata, Japan
TEL
0252574767
tagu@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Taguchi |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata, Japan
TEL
0252574767
Homepage URL
tagu@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Niigata University of Health and Welfare
Tel
0252574767
tagu@nuhw.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
| 2022 | Year | 07 | Month | 05 | 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
25
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
Main results already published
Date of protocol fixation
| 2022 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2025 | 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 | 07 | Month | 05 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055026
