UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040534 |
|---|---|
| Receipt number | R000046271 |
| Scientific Title | IoT-based observation of fluctuated hearing loss and balance disorders |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2020/05/27 03:35:34 |
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Basic information
Public title
IoT-based observation of fluctuated hearing loss and balance disorders
Acronym
IoT-based observation of fluctuated deafness and balance disorders
Scientific Title
IoT-based observation of fluctuated hearing loss and balance disorders
Scientific Title:Acronym
IoT-based observation of fluctuated hearing loss and balance disorders
Region
| Japan |
Condition
Condition
hearing loss and balance disorders
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct daily hearing tests and perturbation tests for inner ear disorders (hearing loss and balance disorder: both are often combined) to be examined by an otolaryngologist and observe continuous changes in symptoms at home.
Basic objectives2
Others
Basic objectives -Others
Diseases where daily observation are useful and their fluctuation patterns.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daily hearing and balance data including their fluctuations.
Key secondary outcomes
Relationship between the above fluctuations, diagnosis of each disease, and case information other than inner ear function obtained from medical records
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Daily hearing and balance tests
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients of Keio University Hospital Otolaryngology who has an inner ear disorder and is consenting to the study
Key exclusion criteria
- Those who have not agreed to participate in the research. Or if you withdraw your consent.
- Persons who are considered unsuitable for this study by the co-investigators or the representatives based on their medical history such as mental illness and cognitive decline.
- A person who is judged by the research coordinator or the representative that the handling of the measured data is not fully understood.
- The target age is not specified, but if the research coordinator or the representative judges that it is difficult to measure at home using a device, such as children or the elderly, it will be excluded from the target.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Fujioka |
Organization
Keio University
Division name
Department of Otorhinolaryngology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku. Tokyo Japan
TEL
03-5363-3827
ent-group@keio.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Fujioka |
Organization
Keio University
Division name
Department of Otorhinolaryngology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku. Tokyo Japan
TEL
03-5363-3827
Homepage URL
ent-group@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio Center for Clinical Research
Address
35 Shinanomachi, Shinjuku. Tokyo Japan
Tel
03-3353-1211
keio@esct.bvits.com
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
| 2020 | Year | 06 | Month | 30 | 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
| 2020 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 27 | 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
| 2020 | Year | 05 | Month | 27 | Day |
Last modified on
| 2020 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046271
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
