UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043972 |
|---|---|
| Receipt number | R000050225 |
| Scientific Title | Cold/warm-water irrigation into external auditory canal for alleviation of acute vertigo. |
| Date of disclosure of the study information | 2021/04/19 |
| Last modified on | 2023/08/28 21:42:53 |
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Basic information
Public title
Cold/warm-water stimulation for alleviation of acute vertigo
Acronym
Cold/warm-water stimulation for alleviating acute vertigo
Scientific Title
Cold/warm-water irrigation into external auditory canal for alleviation of acute vertigo.
Scientific Title:Acronym
caloric stimulations as an antivertiginous injection
Region
| Japan |
Condition
Condition
Patients showing unidirectional nystagmus during an acute vertigo attack
Classification by specialty
| Oto-rhino-laryngology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Antivertiginous effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of nystagmus(immediate, after 30min, after 1 hour)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients showing unidirectional nystagmus during an acute vertigo attack
Key exclusion criteria
Patients with ear drum perforation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Munehisa |
| Middle name | |
| Last name | Fukushima |
Organization
Tokyo Women's Medical University
Division name
Otolaryngology
Zip code
123-8558
Address
4-33-1 Kohoku, Adachi-ku, Tokyo
TEL
03-3857-0112
fukushima.munehisa@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Munehisa |
| Middle name | |
| Last name | Fukushima |
Organization
Tokyo Women Medical University
Division name
Otolaryngology
Zip code
123-8558
Address
4-33-1 Kohoku, Adachi-ku, Tokyo
TEL
03-3857-0112
Homepage URL
fukushima.munehisa@twmu.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Tokyo Women Medical University, Adachi Medical Center, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Otolaryngology and Head and Neck Surgery, Kansai Rosai Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Rosai Hospital
Address
3-1-69 Inabaso, Amagasaki, Hyogo, Japan
Tel
06-6416-1221
mfukushima@kansaih.johas.go.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
| 2021 | Year | 04 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After cold/warm-water irrigation to the right external ear, nystagmus are recoded.
Management information
Registered date
| 2021 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050225
