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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040534
Receipt No. 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

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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
Email 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
Email ent-group@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046271

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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