UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049629 |
|---|---|
| Receipt number | R000056516 |
| Scientific Title | The recording of eye movement using portable recording system by patients themselves during vertigo attack |
| Date of disclosure of the study information | 2022/11/29 |
| Last modified on | 2022/11/28 14:19:40 |
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Basic information
Public title
The recording of eye movement using portable recording system by patients themselves during vertigo attack
Acronym
The recording of eye movement using portable recording system by patients themselves during vertigo attack
Scientific Title
The recording of eye movement using portable recording system by patients themselves during vertigo attack
Scientific Title:Acronym
The recording of eye movement during vertigo attack
Region
| Japan |
Condition
Condition
Diseases of which complaint is vertigo attack
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To record and analyze the eye movement during vertigo attack
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recorded movie of eye movement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Device for recording eye movement
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who assent this study and can use the device of this study at home.
Key exclusion criteria
# Patients who do not assent this study.
# Patients who can not use the device of this study at home.
# Patients whose contact information is unclear.
# Patients who are judged to be unsuitable to this study by doctors.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Bell Land General Hospital
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
5998247
Address
500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka, Japan
TEL
072-234-2001
t_imai@seichokai.or.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Bell Land General Hospital
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
5998247
Address
500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka, Japan
TEL
072-234-2001
Homepage URL
t_imai@seichokai.or.jp
Sponsor or person
Institute
Department of Otorhinolaryngology - Head and Neck Surgery, Bell Land General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Research ethics committee, Bell Land General Hospital
Address
500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka, Japan
Tel
072-234-2001
irb@bh.seichokai.or.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 | 11 | Month | 29 | 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
| 2022 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 21 | 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 | 11 | Month | 28 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056516
